header logo image


Page 139«..1020..138139140141..150160..»

‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy – BioPharma Dive

October 15th, 2022 1:45 am

As a top regulator at the Food and Drug Administration, Peter Marks isnt responsible for weighing the cost of the treatments his teams review. But he is worried that some of the drug industrys most promising medicines may not reach patients with uncommon diseases if companies cant figure out how to sell them.

There are an estimated 7,000 rare diseases, many of which affect only small groups of people. Genetic medicines, including RNA-based drugs and gene replacement therapies, could offer a powerful way to treat, and potentially even cure, some of them. But for would-be developers, diseases affecting only a few dozen people might not represent a large enough market to justify the cost of developing and selling a new treatment.

We're not going to find enough philanthropic groups to foot the bill for gene therapies for the hundreds upon hundreds of different diseases that need to be addressed, said Marks, head of the FDAs Center for Biologics Evaluation and Research, at a conference hosted by the Alliance for Regenerative Medicine on Wednesday.

We're gonna have to find a way to make this commercially viable so that industry can find a way forward towards this."

According to Marks, commercial viability for a gene therapy means administering roughly 100 to 200 treatments a year, a threshold that could be difficult to clear in a single country for rare conditions like severe combined immunodeficiences or adrenoleukodystrophies.

It has not escaped our attention at FDA that there have been some clouds on the horizon in gene therapy, said Marks, noting instances when gene therapies were taken off the market or returned by their developers to the original academic researchers.

In Europe, for example, first GSK and then Orchard Therapeutics abandoned one of the first gene therapies approved there, a treatment called Strimvelis for a condition known as ADA-SCID. Only a few dozen patients were ever treated, and Orchard has also handed back rights to a successor treatment. More recently, Bluebird bio withdrew two gene therapiesfrom the EU market after running into difficulties securing reimbursement in several European countries.

Bluebird recently won FDA approval for both of those therapies in the U.S. One, to be sold as Skysona at a cost of $3 million, is for an inherited condition known as CALD that affects about 50 boys each year. Bluebird has said it expects to treat around 10 each year.

In his remarks to the conference, known as the Meeting on the Mesa and attended by many in the cell and gene therapy field, Marks highlighted a few areas where the FDA could help ease hurdles for ultra-rare disease treatments.

The agency is currently putting together a cookbook for developing and manufacturing of bespoke gene therapies, which could help academic groups more easily transfer treatments theyre working on to industry. Its also looking into how to use non-clinical and manufacturing data from one application to speed the review of others that share similar technology.

There are certain pieces of gene therapies that are not like your typical small molecule drug, because they're reused repeatedly, Marks said.

Automated manufacturing could be another solution to help lower the costs of production, which are significantly higher for cell and gene therapies than for other more established drug types.

The FDA is also hoping to get on the same page with other regulators so that developers could be more confident a product they gain approval for in one country would have a good chance of success in others.

Some of [these problems] may relate to how we can make gene therapies for small populations more widely available, Marks said. What may be a tiny population in the U.S. becomes a reasonable sized population when you go globally.

Here is the original post:
'We have to find a way': FDA seeks solutions to aid bespoke gene therapy - BioPharma Dive

Read More...

Discover Medical Advances in Cellular Therapy Research Using Cord Blood for Cancer, HIV, Cerebral Palsy and Autism During World Cord Blood Day 2022 -…

October 15th, 2022 1:45 am

Free virtual conference for World Cord Blood Day 2022 (November 15th) to feature renowned transplant doctors and researchers presenting ground-breaking work in cellular therapy using cord blood to treat cancer, HIV, cerebral palsy and autism. In addition, bestselling author, Delia Ephron, to present her memoir about fighting leukemia, "Left on 10th: A Second Chance at Life."

TUCSON, Ariz., Oct. 13, 2022 /PRNewswire/ -- Innovations using cord blood in cellular therapy, including traditional stem cell transplants and regenerative medicine research, will be featured during World Cord Blood Day (WCBD) 2022. Recommended for healthcare professionals, expectant parents and STEM students, the official virtual conference, hosted by Save the Cord Foundation, will be held on November 15th (register free via Eventbrite).

We are proud to announce the following speakers:

View the full agenda here: https://www.worldcordbloodday.org/online-medical-conference-agenda-wcbd-2022.html

Hosted and organized by Save the Cord Foundation, a 501c3 non-profit, World Cord Blood Day 2022 brings together the cord blood community through numerous live events and activities held around the globe and online. QuickSTAT Global Life Science Logistics, recognized leader in medical shipping and healthcare logistics, is the Official Sponsor. Inspiring Partners include Be the Match (NMDP), World Marrow Donor Association (WMDA-Netcord), Association for the Advancement of Blood and Biotherapies (AABB), Cord Blood Association (CBA), and Foundation for the Accreditation of Cellular Therapy (FACT).

Visit http://www.WorldCordBloodDay.org to register free for the online conference and learn how you can participate on-line or at an event locally in your community (#WCBD22 #WorldCordBloodDay).

About Save the Cord Foundation (Organizer and host of WCBD 2022)

Save the Cord Foundation (a 501c3 non-profit) was established to advance cord blood education. The Foundation provides non-commercial information to parents, health professionals and the public regarding methods for saving cord blood, as well as current applications using cord blood and the latest research. Learn more at http://www.SaveTheCordFoundation.org.

About QuickSTAT Global Life Science Logistics (Official Sponsor of WCBD 2022)

Every day, QuickSTAT, a part of Kuehne+Nagel, safely and reliably moves thousands of critical shipments around the world. For over forty years, QuickSTAT has been entrusted with transporting human organs and tissue for transplant or research, blood, blood products, cord blood, bone marrow, medical devices, and personalized medicine, 24/7/365. QuickSTAT's specially trained experts work with hospitals, laboratories, blood banks and medical processing centers, and utilize the safest routes to ensure integrity, temperature control and chain of custody throughout the transportation process. Learn more at http://www.quickstat.aero.

Media Contact:

Charis Ober

(520) 419-0269

[emailprotected]

SOURCE Save the Cord Foundation

More:
Discover Medical Advances in Cellular Therapy Research Using Cord Blood for Cancer, HIV, Cerebral Palsy and Autism During World Cord Blood Day 2022 -...

Read More...

American Academy of Stem Cell Physicians to Offer Licensed Physicians Board Examination in Regenerative Medicine – GlobeNewswire

October 15th, 2022 1:45 am

MIAMI, Oct. 11, 2022 (GLOBE NEWSWIRE) -- The American Academy of Stem Cell Physicians will be hosting its fall Scientific Congress in Chicago, IL, on Oct. 28-30, 2022. The conference will feature three days of educational and networking events with leading physicians from across the fields of stem cells, live cells, and regenerative medicine. A Board Examination process will be available, creating a pathway for participants to earn a Diplomat and Fellowship Certification in Regenerative Medicine.

The Board of American Academy of Stem Cell Physicians is the official board certifying body of the American Academy of Stem Cell Physicians(AASCP). As a nationally recognized academy with a mission to bring like-minded physicians together to increase awareness and education for the evolving field of regenerative medicine, the AASCP is proud to announce its Fellowship and Diplomat Certification.

In order to be eligible for certification or recertification through the AASCP, licensed physicians in good standing must meet the stringent eligibility requirements that have been defined by the board. AASCP places an emphasis on not only psychometrically evaluated testing and advanced training, but also moral character and experience. Furthermore, AASCP has a clear path toward recertification for qualified physicians. Their standards for recertification include a commitment to continuing medical education, successful completion of a recertification examination, participation in a non-remedial medical ethics program, and additional requirements.

AASCP is known for working with physicians to provide unique opportunities for board certification in their specialty of regenerative medicine. Specifically, the AASCP offers ongoing workshop modules led by esteemed physicians in this field who certify and educate on different treatment approaches and techniques. Another defining characteristic of the AASCP is theircommitment to ongoing education and awareness. To support this goal, the AASCP has developed innovative committees, including its Institutional Review Board and created opportunities for physicians and researchers to submit their work for peer review and exposure.

The AASCP was founded to recognize licensed physicians who have shown a specialty and interest in regenerative medicine. Increasingly, hospitals and medical staff placement agencies are prioritizing hiring Board-Certified Physicians. For this reason, the AASCPfeels it is important to offer qualified professionals a choice when they're researching board certifying bodies.

The American Academy of Stem Cell Physicians (AASCP) is an organization created to advance research and the development of therapeutics in regenerative medicine, including diagnosis, treatmentand prevention of disease related to or occurring within the human body. Secondarily, the AASCP aims to serve as an educational resource for physicians, scientistsand the public in diseases that can be caused by physiological dysfunction that areameliorableto medical treatment.

For further information, please contact WilsonDemenessez at 305-891-4686, and you can also visit us at http://www.aascp.net.

Contact Information: Wislon Demenessezz AASCP account Sales manager wilson@genorthix.com 305-891-4686

Related Images

Image 1: AASCP Chicago lecture

Meeting lecture

This content was issued through the press release distribution service at Newswire.com.

More here:
American Academy of Stem Cell Physicians to Offer Licensed Physicians Board Examination in Regenerative Medicine - GlobeNewswire

Read More...

The Risk-Reward Proposition for CGT Clinical Trials – Applied Clinical Trials Online

October 15th, 2022 1:45 am

As activity in this space grows, so do the hurdles in moving these products forward.

Cell and gene therapy (CGT)its risks and promisesare succinctly summarized in this description of clinical trial number NCT01129544, a Phase I/II study in children born with X-linked severe combined immunodeficiency (SCID-X1), an inherited, rare, and life-threatening disease. The eight-person trial, which began in May 2010, continues today. The following paragraph has been edited.1

Gene transfer is still research for two reasons. One, not enough children have been studied to tell if the procedure is consistently successful. [And] we are still learning about its side effects and doing gene transfer safely. In previous trials, five children developed gene transfer-related leukemia; four are in remission; one died.

If the above information has stifled the research communitys scientific curiosity about CGT, it is not evident. Evidence from numerous sourcesClinicalTrials.gov, the Alliance for Regenerative Medicine (ARM), FDAare chock-a-block with studies, trials, and figures showing these therapies popularity. In the second quarter of 2022, 3,633 such treatments were in development, up from 1,745 in May 2021. The vast majority are in the preclinical stage.2,3

Some sources are revealing more.

Most indicate that academics now have a remarkable presence in the CGT development space, including sponsorship. Last year, for the first time, ARM included sponsorship figures in its twice-annual industry report.4 Academic- and government-sponsored trials far exceeded industry for sponsored trials in CGT. Stephen Majors, senior director for public affairs, ARM, says the alliance knew of academias presence for the past few years, but only was able to get data this year from its partner, Global Data.

Less reliable, but still noteworthy, are data from ClinicalTrials.gov: for active Phase I trials, industry has 89; others, which covers academia and government, have 50. Industry enrollment for Phase I is 172; others, 116.Phase III is one for others, eight for industry.

A little disruption in pharmas corner of the world? It seems that way. While basic bench to preclinical to clinical trial has long been the traditional route to FDA approvaland no one interviewed for this article suggested a reroutewhat it does imply is that pharma members have some competition from the spin-offs and academic biotechs that historically they have absorbed.

There are suspected trends that we are watching, says Majors.As to whether academias presence in this spot can be called a trend depends on ones definition of what a trend is. The Centers for Disease Control and Prevention (CDC) considers changes over a number years to determine a trend; financial investment firms typically evaluate over a two-year period.Considering that CGT companies raised $23.1 billion in 2021, 16% more than 2020,3 the answer to the above question could be, maybe.

The CGT space is still immature, according to Mike Rea, founder of Protodigm, a self-described exploratory research organization that partners with biopharma clients on alternative development and commercial solutions. Physicians need time to be comfortable with these therapies, notes Rea, so they may not be used on a regular basis.

For example, physicians have to understand how to deliver the gene, agrees cardiologist Arthur M. Feldman, MD, PhD, whose lab worked on a heart failure-related mutation in BAG3 for decades.

Last month, the company he founded, Renovacor, agreed to be acquired by Rocket Pharmaceuticals.5 We are asking physicians to do something they never did before and to understand a very different set of information, including risk/benefit discussions that they didnt learn about in medical school, he says. Feldman is a Laura H. Carnell Professor of Medicine, Division of Cardiology, and a member of the Center for Neurovirology and Gene Editing at the Lewis Katz School of Medicine at Temple University.

Chris Learn, Parexels vice president of cell and gene therapy, is unequivocal regarding academias increased presence in the drug development space focused around these treatments. He cites MD Anderson and Moffitt Cancer Center as two institutions that are sponsoring their own trials. The lines are really blurring here, he tells Applied Clinical Trials. It is indisputable.

The following is a look at how academia is showing up in various reports.

In its 2022 report4, ARM separated sponsorship, type of therapygene, cell-based, and tissue engineeringand trial phase. What these data show are industry far exceeding academic and government sponsored trials for gene therapy, while for cell therapy alone, the reverse is true: 656 cell therapy trials for academic and government, and 424 for industry. For gene therapy, there are 84 for the academics and government, and 222 for industry. In a later report, ARM found non-industry trials dropped.

Pharma Intelligences Pharma R&D Annual Review does not break down trials by their sponsors. It does, however, break down whats in the pipeline in various categories, including by the number of therapies per company, and by disease type.6 In numbers captured prior to March 2020, the analysis reported 1,849 companies with asingle drug in its pipeline, up from 1,633 in 2019, comprising more than half of all drug companies. As for types of therapies, gene therapy was in third place, the same spot it occupied in 2019. (Cancer-related therapies occupy the top spots.) Overall, biotech therapies in the pipeline increased by 13.2% in 2020 over 20196,135 vs. 5,422. Cellular therapy, the field in which academia is dominating, rose to 14th place, up from 33.

In 1982, Feldman was a resident in the cardiac care unit at the Johns Hopkins Hospital in Baltimore when he took care of a 22-year-old woman, a native Pennsylvanian, who was dying of heart failure. Sadly, we didnt have drugs with which to treat her, he recalls. Feldmans involvement with the case and the womans family led to his career as a cardiologist, he says. Twenty years later in Philadelphia, he was asked to see a heart-failure patient in consult, who turned out to be the aunt of the younger woman. It would take almost another 10 years until the technology became available to identify the genomic anomaly in this family. Here, a genetic variant that is produced by one of two alleles causes the protein product to be unstable. The result: the cell removes it, so the person with the variant has just half the amount of required protein.

BAG3 is an interesting protein that is found in the heart, the skeletal muscles, and the nervous system, including the brain. Its function is to help remove degraded and misfolded proteins, stop apoptosis or programmed cell death, and maintain the structure of the skeletal muscles. A missing allele isnt the only genetic cause for heart failure, Feldman said. Other patients, while having the correct amount of DNA, have a point mutationa single amino acidin half of the produced DNA. That single letter is the wrong amino acid in the specific site in the protein.

Around this time, Kamel Khalili, PhD, Laura H. Carnell Professor, and chair of the department of microbiology, immunology, and inflammation; director of the Center for Neurovirology and Gene Editing; and director of the Comprehensive NeuroAIDS Center, Lewis Katz School of Medicine, Temple University, had created a method by which he could excise the HIV virus from patients using the new technique of CRISPR-Cas9.

Khalili believes that BAG3 may be involved in the pathogenesis of HIV-1 in brain diseases and protein quality control caused by viral infection as well as several other disorders, including Alzheimers disease and dementia. BAG3 changes the homeostasis of the cell, he says. The only solution is to fix the cell. Khalili has used CRISPR technology to excise the viral genome in both small and large investigational animals and has recently started a Phase I trial to test the safety of the new gene-editing treatment. Khalili, too, started a company, but Temple holds the license. In the case of Renovacor, it was granted the license by Temple.

As a scientist, when you are doing something in biomed research, [the] goal is to translate bench work to the clinic for [the] wellness of people. We are doing long hours and long days because we want to help. We are trying to see if discovery can help people, says Khalili. I know my limit, I stop at business aspects. My interest is to discover research which can help populations.

Was Feldman happy with his business experience? As a company gets bigger, others join the team who fulfill other roles, like acquiring funding or developing the actual product, he says. Releasing the control reins are difficult. But if it speeds up the timeline to get an approved product into the clinic, then its all worth it, he adds.

Researchers such as Feldman and Khalili, says Kaspar Mossman, PhD, director of communications and marketing at QB3, a University of California biotech accelerator, are normally not deeply interested in business. He notes the new flagship space in UC Berkeley called Bakar Lab. So far, it has 25 companies, one-third from university labs. They collaborate, they share equipment, [at times] they merge, Mossman tells Applied Clinical Trials.

And, he adds, Academics tend to be very smart individuals. The more time they spend in business, they learn stuff and become serial founders, says Mossman. They are honest about not wanting to be a CEO.

In terms of business, the academics employers are also pretty smart. The huge bugaboo with CGT commercialization is the manufacturing processthe need for an apheresis unit, ultra-cold storage, and regulated cell processing facilities.

Some institutions are building their own manufacturing facilities to more easily meet the increasingly complicated standards pertaining to regenerative medicine production. Harvard, MD Anderson, Moffitt, the University of Pennsylvania, and the University Hospital of Liege in Belgium8 all have or are planning to build their own facilities.

As for how academias presence impacts the traditional pharma space, those interviewed cited pros and cons. More research is better, more companies vying for venture capital funding is not. But more trials mean more competition among similar therapies, which, says Majors, is a good thing.

We need experimentation, adds Rea. If left to pharma, he says, the research wouldnt happen. Smaller biotechs are taking the risk. Over the last 10 years, Rea believes pharma has been slow in the risk-taking department. Once upon a time, pharma didnt have many competitors. Now, with many numerous smaller companies with viable assets, willing to accept a smaller net profit, the competition is creating some angst. Pharma cant project everyones movement, says Rea. The gene/cell therapy landscape [for products] is huge.

Likely adding to the angst: Those smaller biotechs are getting financial help. Between April 4, 2021, and June 24, 2021, of 23 start-up financing deals, 19 involved academics.2

Learns viewpoint is different. He says there are too many players out there, and while large pharma may be averse to risk, I really do believe what we are witnessing are simply market forces that have played into this. There is so much cash coming in, he continues, that people can be blinded by the pitfalls. The CGT area, he adds, is bloated and he says the industry needs an overall strategy.

Learn doesnt think that academias presence in the CGT space is a flash in the proverbial pan. The enthusiasm to find cures is real, and some research institutions have the endowments to see the trials through. I think it is just the beginning, says Learn. Academia will put their futures in front of them. Why put all your sweat equity into it and not have any fiduciary benefit of the approved product?

In Pharma Intelligences 2020 Pharma R&D Review, its author questioned the wisdom of so many drugs, overall, in the pipeline4,001 added in 2018 and 4,730 added in 2019, for a total of 17,737 drug candidates. [A]re the industrys eyes getting too big for its belly? Unless it can continue to provide [approved therapies] then a certain degree of control in the pipeline might be advisable, the report stated.6

And now to costs. While no one doubts these cures change lives, the question of access persists. FDAs approval of Bluebird Bios second therapy this year, branded as Skysona, for early but active cerebral adrenoleukodystrophy, is expected to cost $3 million. Learn doubts that payers are jumping up and down to get Skysona on their formularies.

Its still a fairly dicey business proposition for companies to invest in this field, Steven Pearson, MD, president of the Institute for Clinical and Economic Review (ICER), said recently.8Theres still a risk that next-generation therapies will not flourish even in developed countries health systems, he added.

One positive development in the US, however, occurred late last month when Congress reauthorized the Prescription Drug User Fee Act (PDUFA) for the next five years, 2023-2027. The action maintained FDAs authority to collect fees from manufacturers and keep and recruit agency staff to review the increased number of CGT applications. Majors says most of FDAs review of CGT products involves scalability and consistent reproducibility in the manufacturing process, which, of course, means traveling.

According to a Senate press release9, FDA is seeking to hire at least 320 new staff members. In a statement, Pharmaceutical Research and Manufacturers of America (PhRMA) said a modern regulatory framework supported by PDUFA helps ensure patients have timely access to lifesaving medicines.

PDUFA reauthorization aside, there is little argument that the field of CGT, from research and drug discovery through commercialization, is advancing rapidly. In turn, so are the unique operational and manufacturing challenges that these therapies present. This reality may thin the currently crowded playing field in CGT going forward, with those sponsors and partners best prepared to deliver on the numerous touchpoints required separating from the pack.

Christine Bahls, Freelance Writer for Medical, Clinical Trials, and Pharma Information

Read the original here:
The Risk-Reward Proposition for CGT Clinical Trials - Applied Clinical Trials Online

Read More...

Cell therapy weekly: Ray Therapeutics and Forge Biologics expand partnership – RegMedNet

October 15th, 2022 1:45 am

This week: Vita Therapeutics raises US$31 million in Series B funding to progress cell therapies for neuromuscular diseases to clinic and expand its discovery pipeline, Cellusion and Minaris enter business alliance to manufacture cell therapy for bullous keratopathy and Ray Therapeutics and Forge Biologics expand partnership to include plasmid DNA manufacturing.

Vita Therapeutics (MD, USA) announced it has secured US$31 million in Series B financing to accelerate its lead program VTA-100, for limb-girdle muscular dystrophy, to the clinic. The funding will also be utilized to develop Vitas newest program VTA-120 to treat facioscapulohumeral muscular dystrophy and to continue expansion of the companys discovery pipeline. The financing was led by Cambrian Biopharma (NY, USA) and Solve FSHD (Vancouver, Canada).

Douglas Falk, CEO at Vita Therapeutics stated: The support from this strategic group of quality investors further validates Vitas cell therapy platform and our mission to bring transformative therapies that target the root cause of disease to patients with muscle disorders and cancers. This syndicates confidence in our ability to further progress our programs is energizing and we are thrilled to have them as partners. We are making notable progress with our investigational IND-enabling studies for VTA-100 and are on track to reach the clinic with this important therapeutic candidate within 18 months. Additionally, we are excited to further expand our pipeline to include VTA-120 for the treatment of patients with FSHD. Im incredibly proud of our entire team and the steady momentum we continue to have.

Read more

Cellusion Inc. (Tokyo, Japan) and Minaris Regenerative Medicine (NY, USA) announced a letter of intent for the manufacturing of CLS001, Cellusions novel cell therapy treatment for bullous keratopathy. CLS001 utilizes corneal endothelial cell substitute from induced pluripotent stem cells for regeneration of the corneal endothelium. Under the letter of intent, the two companies will together develop the manufacturing process of CLS001 and Minaris will optimize processes to meet FDA requirements.

Shin Hatou, CEO of Cellusion stated: We are very enthusiastic to have the partnership with Minaris, a well-established regenerative medicine partner with over 20 years experiences including the predecessor companies, Progenitor Cell Therapy and Hitachi Chemical, and one of the leading CDMOs in the U.S. since the dawn of the field. Together, we make our best efforts to develop the robust manufacturing process of CLS001 for patients suffering from bullous keratopathy due to the cornea donor shortage all over the world.

Read more

Ray Therapeutics (CA, USA) and Forge Biologics (OH, USA) announced their existing manufacturing partnership will expand to include clinical stage plasmid DNA production to support Ray Therapeutics retinitis pigmentosa gene therapy program, RTx-015. The program currently utilizes Forges platform of manufacturing processes, including its proprietary HEK 293 suspension Ignition Cells and pEMBR adenovirus helper plasmid. To further aid the RTx-015 program, Forge will now also provide plasmid manufacturing services, as well as adeno-associated viral vector process development, scale-up engineering, and cGMP manufacturing services.

Paul Bresge, CEO of Ray Therapeutics stated: By adding clinical grade plasmid production to their existing suite of AAV manufacturing capabilities, Forge is easing the scope of production and accelerating the development of our lead therapeutic. Offering everything we need under one roof integrates our entire process so that we can focus on our mission to restore vision in patients losing their sight as fast as possible.

Read more

You might also like:

Read more:
Cell therapy weekly: Ray Therapeutics and Forge Biologics expand partnership - RegMedNet

Read More...

FDA Expands Oversight of Cell and Gene Therapies – Pharmaceutical Technology Magazine

October 15th, 2022 1:45 am

CBER maps modernization plan to handle surge in research and applications.

FDAs Center for Biologics Evaluation and Research (CBER) is updating how it manages a growing volume of cellular and gene therapy development programs, seeking added resources and revisions in its oversight of these cutting-edge therapies. Most visible in the elevation of CBERs Office of Tissues and Advanced Therapies (OTAT) into a new super Office of Therapeutic Products (OTP). The change aims to improve functional alignment, increase review capabilities, and add expertise on new cell and gene therapies by establishing multiple branches and divisions in the expanded regulatory unit, as announced in the Federal Register on Sept. 28, 2002.

Stated goals are to help CBER address the substantial growth in innovative, novel products that present new scientific, medical and regulatory challenges that require changes to its structure, including strategies to advance the Regenerative Medicine Advanced Therapy (RMAT) program. The added resources are needed to oversee more than 2000 development programs involving cellular and gene therapies, many involving innovative testing and manufacturing processes. This soaring workload has over-taxed CBER staffers, resulting in serious difficulties in retaining and hiring capable scientists.

The structural changes at CBER reflect agreed-on plans to hire new staffers with funding from recently reauthorized user fee programs. The PDUFA VII commitment letter calls for an additional 132 new hires for CBER in this coming year and another 48 employees the following year, most to support cell and gene therapy reviews at OTP. The reorganization plan calls for OTP to have seven officesfor therapeutic products, clinical evaluation, review management, pharmacology/toxicology, and two for CMCfor gene therapy and for cellular therapy and human tissues. There will be 14 divisions and 32 branches within those offices, providing attractive supervisory opportunities for both new and experienced staffers.

These changes come in the wake of FDA approval of two new gene therapies that have drawn wide attention for both their therapeutic potential and for million-dollar price tags. Bluebird bios Zynteglo was approved by FDA in August for patients with beta thalassemia, an inherited blood disorder causing serious anemia. That was followed a few weeks later with approval of Bluebirds Skysona to treat a rare neurological disorder afflicting young boys. Zynteglo carries a $2.8 million price tag, Skysonas list price is $4 million, but both therapies are expected to target fewer than 1500 patients, limiting the overall cost impact for the US healthcare system. A greater spending effect would come from FDA approval of a new treatment for sickle cell disease from Vertex Pharmaceuticals and CRISPR Therapeutics, which plan to begin a rolling review by FDA in the coming months. The important potential benefits of these treatments, along with concerns about their impact on healthcare spending and access, speaks to the need for a highly capable and sufficiently resourced FDA oversight program.

These developments also highlight the importance of sound testing and production methods for therapies made from living organisms, which are inherently variable and difficult to control and measure to assure product safety, identify, quality, purity, and strength. The surge in applications from a broad range of firms, moreover, has made it difficult for CBER staffers to schedule formal meetings with each sponsor seeking advice on how best to perform manufacturing and testing processes. And publishing new guidance on these changing and emerging issues also takes time and resources.

In response, FDA looks to engage a broad range of sponsors on topics related to product development through a series of virtual town hall meetings. The first was held Sept. 29, 2022 and addressed how manufacturers should describe and inform FDA about chemistry, manufacturing, and controls (CMC) in applications for gene therapies. Wilson Bryan, OTAT (now OTP) director, opened the session by describing plans for establishing OTP as a super office to increase review capabilities and enhance expertise on gene and cellular therapies and set the stage for OTP branch chiefs to field a broad range of queries, ranging from basic CMC policies for various stages of development, to the scope of potency assays and impact of delivery devices on dose potency and quality [a recording of the town hall meeting is available at the FDA events link].

Main topics were comparability testing, assays for product characterization, and process controls. OTP staffers emphasized the importance of determining process requirements early in development to avoid late changes and analytical method variability that could raise uncertainties likely to delay clinical trials. Products with complex mechanisms of action, they advised, stand to benefit from early product characterization and potency assay development. And developers of gene therapies should use multiple production lots during a clinical study to ensure product consistency and quality, even for treatments for very small patient populations.

Manufacturers raised questions about differing CMC issues between early Phase I and late-stage clinical trials and voiced concerns about product characterization related to autologous cell-based gene therapies. A main theme from FDA was the importance of sponsors establishing a well-controlled manufacturing process and qualified analytical testing well before administering any new gene product. While CBER plans to issue guidance on manufacturing changes and comparability for cellular and gene therapy products, the information provided at this session provides unofficial guidance for implementing changes in product manufacturing and the scope of comparability assessments and development studies expected to support such changes.

Jill Wechsler is Washington editor for Pharmaceutical Technology.

Go here to see the original:
FDA Expands Oversight of Cell and Gene Therapies - Pharmaceutical Technology Magazine

Read More...

The Health Benefits Of Sea Moss, According To Experts – Forbes

October 15th, 2022 1:45 am

While sea moss has been harvested and consumed either as food or for healing for thousands of years, there is limited scientific evidence to prove many of these claims, says Carrie Lam, M.D., a physician specializing in family medicine and anti-aging and regenerative medicine at The Lam Clinic in Tustin, California. However, new research into its benefits shows promise in the ability of sea moss to treat inflammation and related disorders, she adds.

There are more studies on the benefits of seaweeds as a whole than on sea moss itself. Preliminary research on sea moss thus far is based on small studies. Large-scale clinical trials are needed to verify the findings listed below.

Your thyroid [a small gland located at the base of your neck] needs iodine to produce thyroid hormones, says Dr. Lam. These hormones, important for proper thyroid function, also play a role in metabolism, she explains. Iodine must be acquired through diet because the body cannot make it on its own.

An iodine deficiency can lead to an enlarged thyroid (or goiter), hypothyroidism and intellectual disabilities in infants and children whose mothers were iodine deficient during pregnancy, according to the American Thyroid Association.

While iodine deficiency has been virtually eliminated in the U.S. since the introduction of iodized salt, even a minor deficiency can cause adverse effects on the thyroid.

In the marine environment, seaweeds are the largest supplier of iodine. However, the iodine content varies among different species, with brown seaweed typically having a greater amount compared to green and red seaweeds. Sea moss in particular contains an average of 3.86 1.49 milligrams of iodine per kilogram dry weight.

Most adults need about 150 micrograms of iodine a day, with pregnant and lactating individuals needing slightly more at 220 micrograms and 290 micrograms, respectively, according to the National Institutes of Health.

An unhealthy gut has an imbalance of gut bacteria. This imbalance or gut dysbiosis is linked to disorders such as inflammatory bowel disease, type 2 diabetes, high blood pressure and cancer.

Prebiotics are a group of fibers that are resistant to digestion. They help stimulate the growth and/or activity of the guts good bacteria.

A review of studies on the effects of seaweeds (including sea moss) as a whole in human, animal and in vitro (microorganisms), suggests that certain components unique to seaweeds have the potential to act as prebiotics and support gut health.The authors of the review note that while these trials show the prebiotic potential of seaweed components, large scale human clinical trials are required to validate findings.

The various nutrients in sea moss not only help build muscles and maintain muscle health but also help maintain a healthy bone structure, notes Dr. Lam. This is of much importance to those on a strict exercise regime or the elderly who tend to see a loss in muscle and bone mass due to the aging process, she says.

A small 2018 observational study looked at the effects of sea moss supplementation in 80 patients with musculoskeletal diseases and joint related symptoms. Subjects were divided into two groups treated with different sea moss supplements.

Some of the study participants from both groups reported beneficial effects such as more strength and energy and less exhaustion and pain after supplement treatment. Researchers concluded that this may be due to the high protein content in sea moss. Notably, subjects given the sea moss supplement with greater protein content had higher muscle energy recovery.

There are other potential health benefits of sea moss. However, as these benefits have only been observed in animal and in vitro studies, further clinical trials on humans are needed.

Tap Into The Health Benefits Of Magnesium

Akasha Naturals Magnesium Glycinate promotes muscle relaxation and anti-oxidation, optimizes calcium utilization, improves nerve conduction, and offers superior absorption.

Go here to see the original:
The Health Benefits Of Sea Moss, According To Experts - Forbes

Read More...

Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss – Business Wire

October 15th, 2022 1:45 am

LEXINGTON, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced that it has completed enrollment of its placebo-controlled Phase 2b study of FX-322 in adults with acquired sensorineural hearing loss (SNHL). The FX-322-208 study, which enrolled 142 individuals, is designed to show improvement in a pre-specified measure of speech perception. The Company plans to release study data in the first quarter of 2023.

I am very pleased with our teams execution of this study for the first potential treatment to restore hearing for those with SNHL. The 208 study was rigorously designed to ensure the stability of an individuals hearing prior to entering the trial and to exclusively enroll those with the types hearing loss where we observed the strongest hearing improvement in prior FX-322 studies. FX-322 continues to have a favorable safety profile and we are aligned with FDA on the primary speech perception endpoint. With a successful outcome of this single-dose study, our intent is to advance the program into Phase 3 trials, said David L. Lucchino, Frequencys chief executive officer.

Mr. Lucchino continued: We are grateful to all the study volunteers, clinicians and site staff for their time and commitment to this trial. We believe the high level of interest from patients and healthcare providers in this study further demonstrates the need for a novel, disease modifying hearing loss treatment to expand the standard of care for the millions of individuals with sensorineural hearing loss.

FX-322-208 Study Design

FX-322-208 is a prospective, randomized, double-blinded, placebo-controlled, multi-center Phase 2b study designed to evaluate the efficacy of a single administration of FX-322 on speech perception in subjects aged 18-65 with hearing loss associated with either noise-induced or permanent idiopathic sudden SNHL. The study enrolled 142 participants, exceeding the original enrollment target of approximately 124, and is being conducted at 28 clinical sites across the US.

The Company previously aligned with the US Food and Drug Administration (FDA) on the use of the specific speech perception primary endpoint. With improved speech perception, individuals may hear words more clearly, a critical unmet need for individuals with hearing loss. The FX-322-208 study is powered at 80% (significance level of 0.05) to observe a statistically significant and clinically meaningful improvement in speech perception at day 90 following dosing, with study responders defined as individuals exceeding the upper 95% confidence interval in the speech perception test. The Company has not publicly disclosed the specific test used for the primary endpoint to maximize the rigor of the study and mitigate potential bias.

During the study, subjects participate in a range of audiologic exams, including pure-tone audiometry, word recognition in quiet, word recognition in noise, the Tinnitus Functional Index (TFI), as well as multiple patient-reported outcome measures including Frequencys proprietary patient reported outcome instrument (RADIAL) in acquired SNHL. All subjects are required to have a documented audiogram from at least six months prior to screening and most patients are evaluated over a 270-day period following dosing. The studys rigorous design includes a lead-in phase with multiple baseline measures. Subjects with instability of baseline tests are disqualified from participation in the study. Study audiometry testing sessions are recorded and monitored by third party audiologists to ensure consistency and identify any anomalies related to how tests were conducted.

In prior studies, the Company observed the greatest concentration of speech perception improvements in individuals with permanent sudden or noise-induced sensorineural hearing loss in the moderate to lower severe hearing loss range. These learnings informed the design and inclusion criteria for the FX-322-208 study. More than 200 individuals have been dosed with a single injection of FX-322 in prior or ongoing studies, and the drug candidate has continued to exhibit a favorable safety profile with no drug-related serious adverse events.

About Sensorineural Hearing Loss

Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to sensory hair cells in the cochlea. These cells convert sound waves to signals sent to the brain which are interpreted as speech and sound. Sensory hair cells are lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of hearing loss impacts around 40 million individuals in the U.S. alone.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function first in hearing loss and then in multiple sclerosis by developing therapeutics that activate a persons innate regenerative potential within the body through the activation of progenitor cells. Frequencys hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute.

For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and design of the Phase 2b study (FX-322-208), including the timing of results and the ability of design features to reduce bias, the commencement of any future FX-322 trials, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the treatment potential of FX-322, estimates of the size of the hearing loss population, the acceptance by the FDA of particular endpoints in the Companys trials, and the potential application of the progenitor cell activation (PCA) platform to other diseases.

These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Companys ongoing and planned clinical trials, research and development and manufacturing activities, the Companys business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Companys need for additional funding to complete development and commercialization of any product candidate; the Companys dependence on the development of FX-322; the unproven approach of the PCA platform and the inability to identify additional potential product candidates; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; the Companys limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; ability to seek and receive Breakthrough Therapy designation for FX-322; the Companys ability to enroll and retain patients in clinical trials; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with changing laws and regulations, including healthcare and environmental, health, data privacy and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property rights covering product candidates; security breaches or failure to protect private personal information; attracting and retaining key personnel; and the Companys ability to manage growth.

These and other important factors discussed under the caption Risk factors in the Companys Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2022 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this press release.

See the original post here:
Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss - Business Wire

Read More...

ProKidney Announces Multiple Abstracts Selected for Presentation at the American Society of … – The Bakersfield Californian

October 15th, 2022 1:45 am

- Company will present five posters discussing REACT and chronic kidney disease during the ASN Annual Meeting, November 3 - 6, 2022

- Investor and analyst scientific briefing to be hosted in Orlando, FL on November 3, 2022

WINSTON-SALEM, N.C., Oct. 14, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (ProKidney), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that the Company will present five posters on REACT and CKD at the upcoming American Society of Nephrologys (ASN) Kidney Week being held November 3-6, 2022, in Orlando, FL.

Details for the poster presentations are as follows:

Session Title: CKD: Epidemiology, Risk Factors, Prevention I [PO2201-1]

Session Date, Time: November 3, 2022, from 10:00 AM to 12:00 PM

Poster Board #: TH-PO887

Session Title : Genetics, Development, Regeneration [PO0500]

Session Date, Time: November 4, 2022, from 10:00 AM to 12:00 PM

Poster Board #: FR-PO394

Session Title: CKD: Epidemiology, Risk Factors, Prevention II [PO2201-2]

Session Date, Time: November 4, 2022, from 10:00 AM to 12:00 PM

Poster Board #: FR-PO905

Abstracts can be accessed online at https://www.asn-online.org/education/kidneyweek/.

ProKidney also announced today that it will host an investor and analyst scientific briefing, followed by a reception, the evening of November 3, 2022, in Orlando, FL. To register for the event, or for additional information, please contact Dr. Glenn Schulman at glenn.schulman@prokidney.com. Following the event, a copy of the presentation slides will be available on the Companys website at https://investors.prokidney.com/news-events/events-and-presentations.

About ProKidney

ProKidney, a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidneys lead product candidate, REACT (Renal Autologous Cell Therapy), is a first-of-its-kind, patented, autologous cellular therapy with the potential to not only slow and stabilize the progression of CKD, but in some cases potentially drive meaningful improvement in kidney function. Late-stage CKD patients, Stage 3b - 4, is a key target population for REACT therapy. REACT has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program that launched in January 2022. For more information, visit http://www.prokidney.com.

About CKD

There are no therapies that effectively reverse late-stage CKD. CKD is a serious diagnosis with significant morbidity and mortality. Notably, the 5-year mortality of newly diagnosed Stage 4 CKD is higher than that of newly diagnosed non-metastatic cancer. CKD most often presents as a progressive decline in kidney function, ultimately resulting in the failure of the kidneys and the need for renal replacement therapy, such as hemodialysis or kidney transplant. One in three Americans is at risk for CKD which currently affects approximately 75 million people in the United States and Europe and over 400 million across Asia. CKD is among the largest single expenses incurred by the U.S. health care system.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. ProKidneys actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as expect, estimate, project, budget, forecast, anticipate, intend, plan, may, will, could, should, believes, predicts, potential, continue, and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the combined companys expectations with respect to financial results, future performance, development and commercialization of products, if approved, the potential benefits and impact of the combined companys products, if approved, potential regulatory approvals, anticipated financial impacts and other effects of the business combination on the combined companys business, and the size and potential growth of current or future markets for the combined companys products, if approved. Most of these factors are outside of the combined companys control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the combined companys Class A ordinary shares on the Nasdaq following the business combination; the inability to implement business plans, forecasts, and other expectations and to recognize the anticipated benefits of the business combination or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the combined company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the inability of the combined company to raise financing in the future; the inability of the combined company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the combined company to identify, in-license or acquire additional technology; the inability of combined company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the combined companys products, if approved, and its ability to serve those markets, either alone or in partnership with others; the combined companys estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the combined companys financial performance; the combined companys intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the impact of COVID-19 or geo-political conflict such as the war in Ukraine on the combined companys business; and other risks and uncertainties indicated from time to time in the proxy statement relating to the business combination, including those under Risk Factors therein, and in the combined companys other filings with the Securities and Exchange Commission. The combined company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The combined company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Information

Investors & Media

Glenn Schulman, PharmD, MPH

SVP, Investor Relations

glenn.schulman@prokidney.com

Read the original post:
ProKidney Announces Multiple Abstracts Selected for Presentation at the American Society of ... - The Bakersfield Californian

Read More...

But Did You See the Gorilla? The Problem With Inattentional Blindness …

October 15th, 2022 1:44 am

Viewers of this video were asked to count how many times white-shirted players passed the ball. Fifty percent of them didnt see the woman in the gorilla suit. Daniel Simons

For more than a decade, my colleagues and I have been studying a form of invisibility known as inattentional blindness. In our best-known demonstration, we showed people a video and asked them to count how many times three basketball players wearing white shirts passed a ball. After about 30 seconds, a woman in a gorilla suit sauntered into the scene, faced the camera, thumped her chest and walked away. Half the viewers missed her. In fact, some people looked right at the gorilla and did not see it.

That video was an Internet sensation. So, in 2010, I decided to make a sequel. This time viewers were expecting the gorilla to make an appearance. And it did. But the viewers were so focused on watching for the gorilla that they overlooked other unexpected events, such as the curtain in the background changing color.

How could they miss something right before their eyes? This form of invisibility depends not on the limits of the eye, but on the limits of the mind. We consciously see only a small subset of our visual world, and when our attention is focused on one thing, we fail to notice other, unexpected things around usincluding those we might want to see.

Consider, for instance, a famous 1995 incident in which police were in hot pursuit of four suspects driving away from the scene of a shooting. After cornering the suspects, the first police officer on the scene, Michael Cox, chased one of them on foot. Other officers arriving on the scene mistakenly thought Cox was a suspect and beat him. Meanwhile, another officer, Kenny Conley, had taken up pursuit of the same suspect and ran right past the altercation. Conley claimed not to have seen Cox or his assailants, and he was convicted of perjury and obstruction of justice.

Conleys conviction raised an intriguing legal issue: Could an eyewitness actually fail to notice an assault like that one? Last year, psychology professor Christopher Chabris and I decided to put Conleys alibi to the test. Although we could not simulate a high-speed police pursuit, we could extract the most critical element: Conleys focus on pursuing a suspect. In our experiment, we asked participants to jog behind an assistant and count the number of times he touched his hat. As they jogged, they ran past a staged fight in which two men appeared to be beating a third. Even in broad daylight, over 40 percent missed the fight. At night, 65 percent missed it. In light of such data, Conleys statement that he didnt even see Cox or his assailants was plausible.

Indeed, most of us are unaware of the limits of our attentionand therein lies the real danger. For instance, we may talk on the phone and drive because we are mistakenly convinced that we would notice a sudden event, such as a car stopping short in front of us.

Inattentional blindness does have an upside. Our ability to ignore distractions around us allows us to retain our focus. Just dont expect your partner to be charitably disposed when your focus on the television renders her or him invisible.

Recommended Videos

Read more here:
But Did You See the Gorilla? The Problem With Inattentional Blindness ...

Read More...

Canadians unaware of diseases that lead to blindness, survey says – CTV News Northern Ontario

October 15th, 2022 1:44 am

A new survey from the Canadian Ophthalmological Society and the Canadian Association of Optometrists says many Canadians especially younger people are under-informed about diseases that lead to blindness.

This news has eye doctors reminding people to get their vision checked. They say individuals could be living with a preventable or treatable disease and not even know it.

"We detect any early eye disease or even general health issues. Its important because most eye diseases, such as glaucoma, diabetes, macular degeneration the earlier theyre diagnosed, the better the outcome is," Dr. Janelle Morin, a Timmins-area optometrist, told CTV News.

Morin said she has seen patients who would have benefitted from coming in sooner.

"There isnt a lot of attention to the fact that eye examinations are important and that eye health can deteriorate, without people being aware that thats the case," Dr. Phil Hooper, of the Canadian Ophthalmological Society, said.

The survey showed that while just over sixty per cent of respondents were aware of cataracts, only a quarter knew that they are the leading cause of blindness in the country.

Over a third of those who had not had their eyes checked in over two years, said it was because they did not see a problem with their vision.

Experts in eye health said it is important to look for warning signs and getting an eye exam every year for children and every two years for adults is a good habit to keep up.

"Any flashing lights, a lot of floaters, things like that. Those are big ones for retinal detachment, that can lead to permanent vision loss Diabetic retinopathy, most of the time, doesnt have any symptoms, until it is too late. Same thing with macular degeneration," Morin said

Though Hooper said there are barriers, like the cost of eye exams and the availability of treatments and surgeries that need resolving.

"To make sure these people dont delay their care until the outcome isnt as good as it otherwise could be," Hooper added.

Experts said that parents in Ontario should make eye exams a yearly habit for their children since theyre covered by OHIP.

And for adults that have not had an exam in a while, they said its better to get one now than regret it later.

See original here:
Canadians unaware of diseases that lead to blindness, survey says - CTV News Northern Ontario

Read More...

A Review of Corneal Blindness: Causes and Management – Cureus

October 15th, 2022 1:44 am

Although most of the eye's focusing power comes from the cornea, the focus is fixed. By altering the lens' shape, accommodation, i.e., the focussing of light to provide a clearer vision of close objects, can be achieved. The epidemiology of cornea is too extensive, including viral ocular disorders, which lead to corneal scarring and inflammatory conditions and finally lead to functional blindness[1]. Globally, the foremost reasons for blindness are uncorrected refractive error, glaucoma, and diabetic retinopathy. With increasing age, the number of people affected by vision loss also increases[2]. To cope with the rising cases, we should take the initiative to set up large-scale eye camps to address these patients. The government should develop various public health programmes and awareness programmes to deal with the current havoc created due to loss of vision targeting the senior population and neonates and children. Approximately 1.4 million children have blindness globally, meaning they are more likely to be in a lower socio-economic class and suffer from socio-economic deprivation[3].

When the cornea is touched, an involuntary reaction to close the eyelid occurs because the cornea possesses unmyelinated nerve endings that are subtle to feel, temperature, and chemicals. A healthy cornea has no need for or necessity for blood vessels since transparency is of utmost significance. The anterior-most part of the eye is the transparent structure forming the anterior one-third of the outer layer called the cornea[4].

The cornea comprises six layers: the corneal endothelium, Dua's layer, Bowman's membrane, corneal stroma, and corneal epithelium.The thickness of the cornea in an adult is 550 microns[4]. The main functions of the cornea are the following: to protect structures inside the eye, the structural barrier, and against environmental infections, and to contribute to the eyes two-third refractive power[5].

It is constituted of two components: the cellular component and the acellular component. Collagen and glycosaminoglycans are included in acellular details, whereas endothelial cells, keratocytes and epithelial cells are included in the cellular part[4].

The various causes leading to corneal blindness are depicted in Figure 1.

Bacterial Keratitis

Bacterial keratitis is the most common type of infectious keratitis in most countries worldwide. The most common bacteria responsible for causing bacterial keratitis is coagulase-negative staphylococci followed by Staphylococcus aureus, Streptococci spp., Pseudomonas aeruginosa and Enterobacteriaceae spp [6].

Fungal Keratitis

There are various species of fungi that cause fungal keratitis eventually leading to corneal blindness. The most common fungi that are involved are Candida, Aspergillus, and Fusarium [7]. In India, the most commonly involved species is Aspergillus which is then followed by Fusarium [8,9]. The prevalence of specific species of fungi depends upon various specific risk factors such as temperature, climatic conditions, and urbanization of that region. The patient-specific risk factors include trauma and contact lens use [10].

The pathophysiology behind fungal keratitis is a defect in the corneal epithelium which gives entry to the corneal stroma. This is the reason for the increased prevalence of this disease in patients with trauma [11].

Herpes Simplex Keratitis (HSK)

The infection caused by the herpes simplex virus is another cause which progressively leads to blindness due to corneal involvement. Keratitis instigated by herpes simplex virus (HSV) type 1 is a primary reason for contagious blindness. Epithelial or dendritic keratitis is the most typical manifestation. With recurrent illness, herpes stromal keratitis can cause progressive corneal opacification and visual loss[12].

The mouth, genitalia, and eyes, however, are the most typical sites of infection in a person with a healthy immune system. Very young toddlers and, in rare cases, adults may also get brain infections. In affluent nations, HSV eye illnesses are the principal infectious reason for corneal blindness[13]. The three types of stromal keratitis caused by HSV are endothelial subtype, epithelial subtype, and stromal subtype. In disciform HSK, the DNA value of the HSV is reduced as compared to the dendritic HSK. The laboratory boosts confidence in identifying HSK subdivisions with the combination of the HSV Immunoglobulin A by the enzyme-linked immunosorbent assay (ELISA) by the use of tear samples along with the procedure of real-time polymerase chain reaction (PCR)[14].

Trachoma

Currently, trachoma is the leading cause of preventable blindness globally. Chlamydia trachomatis bacterial infection is spread through sexual contact, causing chlamydia. It is the furthermost often stated microbial disease in the United States. It is the most prevalent sexually transmitted disease (STD) in the entire world. It produces trachoma, the most pervasive infectious factor behind blindness worldwide, an eye infection[15].

Dry Eye Disease

It was previously known as Keratoconjunctivitis sicca, which was given by Henrik Sjogren. He also established the triad, which included joint pain, dryness of mouth and Keratoconjunctivitis sicca[16]. The patient presents with the symptoms of foreign body existence, itchy and gritty eyes accompanied by excess tears and blurred vision. Furthermore, when the disease is not treated, it leads to further worsening of conditions causing discomfort and eventually causing blindness. The most common affected population is the senior population; the disease prevalence is seen more in females as compared to males. The various causes of dry eye disease are ocular surface dysfunction, blink rate, autoimmune diseases and other disorders[17]. The risk factors that are mainly responsible for the condition are the female gender and the advancement of age. The hormonal imbalance in the females further aggravates the symptoms like the decrease of tear production significantly around 60 years, along with the effect on meibomian gland function and the density of goblet cells of the conjunctiva[16].

The assessment and diagnosis of the diseases are based upon the questionnaires that are specifically developed for dry eye diseases like symptom assessment in dry eye (SANDE) and ocular comfort index (OCI)[18].

Keratoconus

Keratoconus is an illness that causes thinning of the cornea, eventually causing reduced visual acuity and irregular astigmatism. It is a bilaterally asymmetrical disease associated with ocular inflammation. The various risk factors associated with keratoconus are allergy, atopy, eye rubbing and various environmental and familial factors, which are mediated by immunoglobulin E (IgE) [19].

Ophthalmia Neonatorum

This is the conjunctiva disease, a kind of conjunctivitis observed in neonates. This disease frequently spreads following a vaginal birth and is associated with severe side effects such as ocular perforation and ulceration, which may result in lifelong blindness. According to research, this eye condition is caused by a number of microbes, including Chlamydia trachomatis, N. gonorrhoea, infection of the virus, and bacteria from the skin and intestinal system[20].

Non-infectious Neonatorum

It is an autoimmune disease, which is one of the leading reasons for blindness that can be prevented by various measures.

For evaluation of the infectious keratitis, the primary step is the sample collection for culture and direct microscopy using various stains. There might be a need for corneal biopsy for deeper infections [11]. The gold standard techniques for diagnosing the infectious cause leading to corneal blindness remain the same, that is, Gram staining and culture methods which give the results instantaneously[21]. For confirmation of the diagnosis, a PCR is used occasionally because of its high sensitivity.

Fungal Keratitis

The medical treatment currently available includes antifungal agents which are fungistatic that increase the duration of treatment for complete eradication of the causative agent. The drug of choice is topical natamycin 5% and the other topical antifungal agents that can be given are amphotericin B, which is used specifically for yeasts; voriconazole; and itraconazole.

For the patients who do not respond to the given medical treatment, surgical interventions have been used for their treatment. The interventions include lamellar keratoplasty and therapeutic keratoplasty [11].

Bacterial Keratitis

The treatment of choice for bacterial keratitis is the use of topical antibiotics. Fluoroquinolones are most commonly used. Even anti-collagenases and steroids are used for the treatment [22].

In the case of bacterial keratitis, topical antibiotics are the most preferred and primary stay treatment regimen. Even anti-collagenases and steroids can be used in bacterial keratitis[22]. Voriconazole is used for fungal keratitis, which is a newer generation triazole because of its tremendous ocular penetration[23]. The ultimate target for managing the above condition is to decrease inflammation and avoid further eye complications[24].

Dry Eye Disease

Questionnaires like Fluorescin break up time or Ocular Surface Disease Index can be used for diagnosing dry eye disease along with Schirmer's test for detecting decreased tear production; the assessment can also be carried out by stains and by cytology to find out the ocular damage[25,26].

Dry eye disease management can be done by keeping the ocular environment in control, such as avoiding prolonged exposure to digital devices, avoiding the dry atmosphere and using external protection like contact lenses such as silicon hydrogel and scleral lenses[26]. Even lipids can be used with velocity enhancers for the effective treatment of dry eye disease (DED) [27].

Keratoconus

The early detection of keratoconus can be done by more frequent monitoring of the disease progression and performing the indicated interventions at the time, leading to improved patient outcomes so that the use of transplantation of cornea is reduced to a significant amount[19]. The advances for the diagnosis are the corneal biomechanics, various biomarkers like tear inflammatory cytokine or levels of matrix metalloproteinases in the tear immunoglobulin A or by using artificial intelligence[28].

Various treatment modalities are available for the management of keratoconus and for preventing corneal blindness. To prevent further disease progression, the mainstay clinical modality is corneal cross-linking. Various strategies and new molecules have been implicated in the scleral cross-linking. One of the more unknown molecules isolated from the Streptoverticillium sp., named transglutaminase, does not need photoactivation, which makes the cornea stiffer without causing much damage to the underlying layers of the cornea. The others include numerous keratoplasty procedures, transplantation of the Bowman's layer, additive keratoplasty, and cellular therapies[28]. Keratoconus causes the fragmentation of the Bowmans layer in the earliest phase of the disease[29].

The biomechanical support to the cornea is provided by the Bowman's layer, which is also responsible for the maintenance of its shape and keeping it sturdy. Hence, if we replace this tissue, we can stop the further progression of the keratoconus to its later stages and prevent blindness[30]. A femtosecond laser was employed to produce the stromal compartment, which decreased the risk of micro-perforation during manual dissection. Recently, intraoperative optical coherence tomography has allowed for better visibility of the dissection plane[31]. The graft is localised at the mid-stromal level in the traditional approach; however, a recent variation describes inserting the graft as an onlay in the subepithelial region[32]. The additive keratoplasty helps to increase the thickness of the cornea along with biomechanical stability. To avoid immune rejection, an approach towards tissue engineering has been preferred, which enabled better outcomes in the case of visual acuity and in terms of biomechanical effects[28]. Diagnosis of non-infectious uveitis is based on clinical symptoms and the association with systemic diseases[33].

One of the treatment modalities that is used for treating corneal blindness is organ donation. The concept of corneal transplantation for the treatment of blindness was first stated by Himly in the year 1813, but the first transplantation surgery was actually performed by Von Hippel in the year 1886 by replacing the cornea of a rabbit[34]. Anterior corneal opacities were initially treated using lamellar keratoplasty, including the selective removal of layers of the cornea. This treatment modality was actually used to treat the disease keratoconus and also the scarring of the cornea, but it was halted since it didn't provide the best visual gain. This might have been because of the imperfect interface or any remaining opacities[35].

The various types of lamellar keratoplasty surgeries that can be done are anterior lamellar keratoplasty (ALK), superficial anterior lamellar keratoplasty (SALK), automated lamellar therapeutic keratoplasty (ALTK) and others.

Immune Privilege

The three barriers that contribute to the ocular immune privilege of the cornea are anatomical, cellular and molecular. The mentioned mechanisms facilitate immune tolerance to donor antigen. The predisposing factors destroying and interrupting the immune privilege are the following: the previous rejection of the graft, vascularized corneal tissue, and ocular inflammation.

When the immune privilege is interrupted, it leads to corneal graft rejection. It is predominantly a cell-mediated pathway [36].

Intra-operative Optical Coherence Tomography (iOCT)

Continuous feedback on intraoperative surgical manoeuvres is provided by the iOCT. In Lamellar keratoplasty programmes like superficial anterior lamellar keratoplasty, automated lamellar therapeutic keratoplasty, deep anterior lamellar keratoplasty, Descemet stripping endothelial keratoplasty, and Descemet membrane endothelial keratoplasty, it is beneficial. The centre corneal thickness (CCT) of the donor and host corneas, both of which are significant criteria for choosing the blade size to be utilised in the microkeratome for dissection, may be measured using the iOCT. Additionally, it serves as an intraoperative directing aid when donor tissue is manually prepared so that the issues related to this will be further reduced. With the use of iOCT, appropriate coherence may be carried out in situations of superficial anterior lamellar keratoplasty and automated lamellar therapeutic keratoplasty. The iOCT directs every surgical step in the deep anterior lamellar keratoplasty (DALK) process, from the depth of trephination through graft-host apposition[37].

Femtosecond Laser-Assisted Lamellar Keratoplasty (FALK)

The femtosecond laser can be used for laser and total thickness penetrating keratoplasty (PKP). This keratoplasty has various improvements when compared with the manual one[38].

Bioengineered Cornea

This technique was developed for visual rehabilitation and for managing the gap in the availability of donors. Bioengineered cornea includes replacing the part of the cornea or the whole of the diseased cornea[39]. These include various methods ranging from the use of keratoprosthesis that actually supersedes the function of the cornea to the most recent advancement of tissue-engineered hydrogels, which assist in regenerating the tissue of the host[40].

Various public health interventions are needed to decrease the prevalence of corneal blindness. Measures like vitamin A supplements and advice regarding the modification of nutrition, i.e., nutritional assessment and the vaccination against measles can prevent xerophthalmia, which is caused due to Vitamin A deficiency. Implementing the SAFE strategy, which includes Surgery for trichiasis, Antibiotics for infection, Facial cleanliness and Environmental improvement to control transmission, can successfully prevent trachoma, which is caused by Chlamydia trachomatis, causing corneal opacification leading to corneal blindness and decreasing its prevalence. Onchocerciasis can cause blindness due to inflammation caused by the Onchocerca volvulus, which can be controlled by the ivermectin distribution in public along with the control of the Simulium fly. In less developed and developing countries, traumatic corneal abrasion is the most common precipitating factor for blindness due to corneal involvement. Hence, to prevent such blindness due to trauma, a prophylactic topical antibiotic should be taken for a few days, especially in high-risk occupation people as farmers, who have an increased risk for trauma through vegetable matter[41].

Excerpt from:
A Review of Corneal Blindness: Causes and Management - Cureus

Read More...

A cure for blindness may be first product made in space – Freethink

October 15th, 2022 1:44 am

Artificial retinas made in space appear to be better than retinas made on Earth suggesting that a cure for a leading cause of blindness could be one of the first products manufactured on tomorrows commercial space stations.

Vision 101: After light enters the eye, it travels to the retina a thin layer at the back of the organ where light-sensitive cells called photoreceptors convert it into electrical signals. The signals are then sent on to the brain for interpretation.

Many eye diseases damage photoreceptors, leading to vision problems or even blindness. They affect millions of people, and there are no known treatments for the most common ones: retinitis pigmentosa and age-related macular degeneration.

Even a force as light as the pull of gravity during manufacturing can lead to imperfections.

Artificial retinas: Connecticut startup LambdaVision is using a light-activated protein, called bacteriorhodopsin, to build artificial retinas. The hope is that the devices will one day restore vision in people with retinal degeneration by filling in for their damaged photoreceptors.

Activated by light entering the eye, the artificial retina pumps protons toward the bipolar and ganglion cells, explains LambdaVision CEO Nicole Wagner. Receptors on those cells detect the protons, which triggers them to send signals to the optic nerve, where they travel to the brain.

Space build: Each of the artificial retinas contains 200 layers of the protein on a mesh membrane. The more uniform these layers are, the better the implant should work, but even a force as light as the pull of gravity during manufacturing can lead to imperfections.

In pursuit of flawless protein layers, LambdaVision decided to explore the feasibility of manufacturing its artificial retinas in space, the hope being that the microgravity environment on satellites would lead to a better product.

The company teamed up with Space Tango, a space-based research firm, to design an experiment using one of its CubeLabs, boot-box-sized containers packed with all the automated systems needed to perform experiments with near-real-time input from Earth.

LambdaVisions most recent CubeLab prior to flight. Credit: LambdaVision

Backed by a $5 million commercialization grant from NASA, it sent its first CubeLab to the International Space Station (ISS) in 2018, and four others have followed.

[Were looking at] how do you make this as reproducible and as high quality as possible, said Wagner.

The fifth CubeLab has now returned to Earth, and according to LambdaVisions initial analysis, the 200-layer films in it were more uniform than the controls they created on Earth.

This fifth experiment was also the most autonomous yet while LambdaVisions researchers had to frequently intervene with early CubeLabs, this tech inside this one produced the films almost entirely on its own.

Looking ahead: Each microgravity experiment has aided LambdaVision in its goal of meeting the FDAs manufacturing standards for its artificial retinas by the end of 2023, and it already has three more CubeLabs scheduled to arrive at the ISS in the next year.

Weve made a lot of progress, but theres still work to be done, said Wagner. Were continuing to look at the parameters, were continuing to develop these assays. But having made the 200-layer film in microgravity is a big milestone.

The ISS is a research lab. Commercial space stations will have more capabilities.

LambaVision hopes to have its artificial retinas ready for trials involving patients with advanced retinitis pigmentosa in 2024. If those go well, trials to treat age-related macular degeneration would follow.

Ultimately, it plans to work with commercial partners to manufacture the implants in space.

Theres a lot of promise in continuing to do this work in a microgravity environment, Wagner told the Financial Times. But the ISS is a research lab. Commercial space stations will have more capabilities. They will be designed with the future in mind.

Wed love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [emailprotected].

Read the original:
A cure for blindness may be first product made in space - Freethink

Read More...

Is MrBeast trying to cure 1000 people’s blindness? – indy100

October 15th, 2022 1:44 am

Jimmy Donaldson, famously known as 'MrBeast' online, is one of YouTube's highest-paid and most-viewed creators on the platform, with his over-the-top stunts, challenges and generous donations.

Well, the YouTuber who's amassed over 105 million subscribers on his main channel alone is rumoured to be helping 1,000 blind people regain their vision.

In leaked footage posted to YouTube, Donaldson stated just that, after briefly touching on the project on the Flagrant podcast in September.

He said: "The one after that, were gonna try to fix 1,000 peoples eyesight. I think itd be cool. Yeah, cause, like, a lot of people just cant see, and the only reason that is, is they dont have money, which kind of blows my mind."

Sign up to our free Indy100 weekly newsletter

MrBeast Gets Flagrant and Walked Away from $1 BILLION DOLLARSwww.youtube.com

This week, a clip was shared to YouTube via user Breone that showed MrBeast saying: "In this video, we're curing 1,000 people's blindness."

The crowd erupted into cheers while the cameraman stood on a ladder to get the shot.

Details remain sparse, but fans of the YouTuber took to the comments to praise his reported efforts.

MrBeast Is Helping 1,000 Blind People...www.youtube.com

"Just knowing what Jimmie does makes me smile helping dozens or thousands with their condition or status it's just amazing of him," one said, while another joked: "Jimmys becoming Jesus."

A third wrote: "Yet there are dudes that try to cancel this man even though he does all the good things for other people."

Meanwhile, one sceptic wrote: "Imagine he can't help them and doesn't release the video."

Have your say in our news democracy. Click the upvote icon at the top of the page to help raise this article through the indy100 rankings.

See the original post:
Is MrBeast trying to cure 1000 people's blindness? - indy100

Read More...

Early detection and management is the key to prevent glaucoma related blindness: Experts – Express Healthcare

October 15th, 2022 1:44 am

Nearly 1.2 million Indians suffer from irreversible blindness caused due to glaucoma

AbbVie company recently shed light on the need for early diagnosis and treatment for glaucoma.

Currently, early diagnosis and appropriate treatment of glaucoma is possible with medicines, surgery, or laser treatments, so that further vision loss can be prevented or if already present, it can be stabilised in most cases.

Talking about the common causes of glaucoma Dr Ramanjit Sihota, Head, Glaucoma Services, Shroff Eye Centre, New Delhi said You may be at risk of glaucoma if you have a family history of glaucoma or suffer from medical conditions like thyroid disease, high blood pressure, or other cardiovascular problems. Apart from these, those who take steroid-containing medications, have high eye power, or have had an eye injury or surgery should check their eyes regularly for early diagnosis of the condition.

She also emphasised that, Although glaucoma is more common in adults, it can develop at any age. Childhood glaucoma, also commonly known as primary congenital glaucoma, is rare but is responsible for about 4 per cent 8 per cent childhood blindness. An estimated 1 in 10,000 births are affected by primary congenital/infantile glaucoma.

Highlighting the need for timely treatment, Dr Rishi Jain, Medical Director, Allergan, an AbbVie Company said, India faces a considerable challenge in terms of eye care, including poor coverage and access to quality services for prevention, treatment, and rehabilitation. A shortage of trained eye care service providers and poor integration of eye care services into health systems is a leading cause for the growing concern of vision loss.

Glaucoma is an under-recognised and under-treated condition. A timely diagnosis and appropriate management can significantly lower the chances of vision loss. At Allergan, an Abbvie company, we work closely with health care practitioners and communities to raise awareness, engage, and empower people about this condition.

Read more here:
Early detection and management is the key to prevent glaucoma related blindness: Experts - Express Healthcare

Read More...

Tears of happiness: How curing blindness in Dolakha saved a girls future – City A.M.

October 15th, 2022 1:44 am

Friday 14 October 2022 12:00 pm

By: The Tej Kohli and Ruit Foundation

The Tej Kohli & Ruit Foundation has a mission to support and cure people living with needless cataract blindness in developing nations, and in turn eliminate extreme poverty.

Dolakha is located in northeastern Nepal. Popular amongst tourists and natives, its natural beauty, cultural sites and array of hiking trails attract people from far and wide.

One of the largest attractions in the area is the Bhimsen Temple, a site dedicated to one of the brothers in the epic Sanskrit poem Mahabharata. The temple remains incredibly popular due to the fascinating capacity of the statue of Bhismen has to perspire fluid-esque droplets, resembling tears, on occasion.

Nearby is the Kalinchowk Bagawait temple, dedicated to the Hindu Goddess Kali. Myths and lore encircle the temple as prominent figures in Hinduism, such as the Pandavas sons in the Mahabharata are said to have meditated on top of the hill. Today people flock to the area to give thanks and pray to the shrine of Kali.

Members from the Tej Kohli & Ruit Foundation travelled to the area of Dolokha from Kathmandu, some 180km away. The town itself, slightly shadowed by the majestic Himalayas, is often dusted with snow as are the tips of the mountains. Other members of the team had already begun screening people in the hilltop town, so in September 2021, another team travelled into the remote corners of the district to find people suffering from cataracts.

The outreach microsurgical eye camp (OMEC) was set up in the picturesque town and by the early hours of the morning of the first day, patients were queueing up, patiently awaiting their turn.

People of all ages arrived, eager to receive treatment to rid them of the cataracts that had made their daily lives difficult. One patient, a young girl named Jesika, was seen by members of the team clinging to her fathers arm. The team spoke to her father, Bishnu, who disclosed that Jesika had been having trouble seeing the blackboard at school for over two years. When the pandemic struck the area, Bishnu was spending more time at home as he was unable to go to work in India, where he worked in the informal hospitality industry, and he saw just how much his daughters sight had deteriorated. Unable to navigate around the home in the evenings, Bishnu knew that something had to be done to save his daughter from a life of total blindness and all that can come with it.

Doctors allied with the Tej Kohli & Ruit Foundation confirmed that Jesika was suffering from congenital cataracts, a form of cataracts that clouds the lens at birth, and in order to save her eyesight, she must undergo surgery.

Luckily, her surgery was able to be performed at the outreach camp in Dolakha, and later that day Dr Sanduk Ruit a world-renowned surgeon operated on the young girl. Jesika and her family returned the following day to have the patches on her eyes removed and she happily confirmed she was able to see again, leaving her father in floods of joyful tears.

Like the Tej Kolhi & Ruit Foundation, Bishnu was aware of the detrimental effects that blindness can have on women in low-income countries. Unable to work, earn a living and perhaps even safely look after your own children these are all issues that women suffering from needless blindness deal with regularly. Thankfully, since Dr Ruit performed surgery on Jesika she is back in school and thriving, enjoying a social life and working her way towards a brighter future, unbound by the constraints that losing your eyesight can have.

Stories like Jesikas are not unheard of for the Tej Kohli & Ruit Foundation. On this occasion in September 2021, after setting up ten camps and screening 1,576 patients, members of the foundation removed patches of 98 people who were immensely happy to say they could see once again.

Since its commencement in March 2021, The Tej Kohli & Ruit Foundation has screened over 170,000 people and cured the sight of 21,571.

The Tej Kohli & Ruit Foundation is a restricted fund operating under the auspices of Prism The Gift Fund, registered UK charity number 1099682.

See the rest here:
Tears of happiness: How curing blindness in Dolakha saved a girls future - City A.M.

Read More...

As World Sight Day Nears, River Blindness is Fading – SaportaReport

October 15th, 2022 1:44 am

Dr. Kashef Ijaz

Gregory Noland

By Gregory S. Noland, Director, River Blindness Elimination Program, and Dr. Kashef Ijaz, Vice President-Health, The Carter Center

World Sight Day is the second Thursday in October, and we at The Carter Center and our country offices are doing our part to preserve vision in vulnerable populations through our robust river blindness and trachoma programs.

In our August column, Kelly Callahan, director, Trachoma Control Program, described the programs accomplishments, so this column will concentrate on our River Blindness Elimination Program.

River blindness, also known as onchocerciasis, is a parasitic infection that can cause intense itching, skin discoloration, rashes, and eye disease that often leads to permanent blindness. The parasite is spread by the bites of infected black flies that breed in rapidly flowing rivers.

About 20.9 million people are infected with the parasite, with more than 240 million at risk of the disease in sub-Saharan Africa, Latin America, and Yemen.

The Carter Center currently works to eliminate river blindness in Brazil,Ethiopia,Nigeria,Sudan,Uganda, andVenezuela. Together with the respective ministries of health and partners, the Centers Onchocerciasis Elimination Program for the Americas has eliminated river blindness transmission in Colombia (2013),Ecuador (2014),Mexico (2015), andGuatemala (2016) the only four countries in the world to achieve this status.

The Carter Center assists the national ministries of health to eliminate river blindness through health education and mass drug administration (MDA) of the medicine Mectizan, donated by Merck & Co., Inc., Rahway, New Jersey. Mectizan kills the parasite larvae in the human body, preventing blindness and skin disease in infected persons and stopping the transmission of the parasite to others.

We and our partners have made major progress against river blindness in Uganda.

Fred Matalocu, 65, is old enough to remember how river blindness (onchocerciasis) once devastated his community in northwest Ugandas Moyo district. Because of the unbearable itching, disfiguring skin damage, and crippling vision loss caused by the infection, people had to stop farming near the rushing rivers and streams in the area. And it affected him directly.

I have suffered from river blindness by scratching my body, he says. Some people used rough objects [to scratch themselves] as if their fingernails were insufficient objects such as dried maize cobs or sharp stones.

Ugandas Ministry of Health and The Carter Center (as the River Blindness Foundation until 1996) commenced activities in Moyo in 1993 in hopes of controlling onchocerciasis; elimination was not considered possible at that time. However, in 2007, Uganda boldly shifted its river blindness programs goal from mere control to elimination, and significant progress has followed.

Now, after years of treatments with Mectizan, the entire Madi-Mid North focus, including Moyo, has reached the status of transmission interruption suspected a major step toward elimination. In fact, the entire country is on track for elimination of onchocerciasis transmission within the next few years a feat that no country in Africa has yet achieved.

We believe all people deserve to be free of preventable diseases, and if things go according to plan, the people of Uganda soon will be free of this one.

Read this article:
As World Sight Day Nears, River Blindness is Fading - SaportaReport

Read More...

World Sight Day: Orbis, UC Davis team up to train eye care teams from Latin America to fight avoidable blindness – Ophthalmology Times

October 15th, 2022 1:44 am

In the leadup to World Sight Day, global eye care nonprofit Orbis International and UC Davis Health announce the launch today of a two-week training project on board the Flying Eye Hospital a fully accredited ophthalmic teaching hospital on board a plane.

According to a news release,Orbis's clinical staff and Volunteer Faculty (medical experts) along with UC Davis Medical Health physicians and staff will share their knowledge with nearly 50 ophthalmologists, ophthalmology residents, nurses, and biomedical engineers fromBolivia,Chile, andPeru, helping them build skills to fight avoidable blindness in their communities.

Orbis noted in the news release that the ophthalmologists and ophthalmology residents participating in the training will hone their skills using leading-edge ophthalmic surgical simulation training technology on the Flying Eye Hospital, which is currently at Moffett Federal Airfield, inMountain View, California.

The nurses and biomedical engineers will have hands-on training at the UC Davis Health Center for Simulation and Education Enhancement, a state-of-the-art facility focused on supporting interprofessional medical education and research activities, inSacramento, California. Simulation training allows the visiting eye care teams to grow their confidence in a training environment before moving on to real-life surgical procedures.

"Orbis has a long history of training eye care professionals inLatin America. After delivering virtual trainings throughout the pandemic in the region, we are thrilled to host participants once again for in-person training on board the Flying Eye Hospital," Derek Hodkey, president and CEO of Orbis International, said in a news release. "This project represents a wonderful opportunity to provide quality hands-on training through simulation as a means to fight against avoidable blindness around the world."

David Lubarsky, MD, MBA, CEO of UC Davis Health, pointed out that at UC Davis Health, they are committed to health equity and successful outcomes for patients everywhere.

As a nationally ranked teaching hospital, an important part of what we do is share our treatment techniques and medical research with other providers, he said in the statement. This partnership with Orbis will provide training to improve eye health and help prevent blindness in places where access to care is limited, and providers can't easily make it toCalifornia. We're excited about sharing our expertise in this way and taking the training to places where it will help patients around the globe."

Learning surgical skills for cataract removal will be a major focus of the training for the ophthalmologists and ophthalmology residents. Cataracts are the leading cause of blindness inBoliviaandPerudespite being treatable with an operation that can take as little as ten to fifteen minutes. Participants will also learn to treat other conditions that threaten vision, including glaucoma and macular degeneration, respectively the second- and third-most common causes of blindness inBoliviaandPeru. A select group of these participants, who are already highly experienced ophthalmologists, will also participate in a train-the-trainer course, which will deepen their ability to train the next generation of eye care professionals. This helps ensure ongoing continuity of and local access to eye care in their home countries.

Nurses will train in simulated emergency scenarios, patient recovery, operating room procedures and sterilization practices. In addition, nurses will receive an orientation to eye banking and get hands-on experience evaluating corneal tissue at Sierra Donor Services Eye Bank. Senior nurses will also participate in a train-the-trainer course integrated into the nursing training program. Biomedical engineers and technicians will train in ophthalmic equipment maintenance and repair. Part of this training will include a workshop hosted by biomedical engineers from Alcon,a long-time supporter of Orbis.

Forty Years of Innovation at Orbis

This year, Orbis is celebrating 40 yearssince the Flying Eye Hospital took its first flight. Since 1982, three generations of the Flying Eye Hospital have taken training to eye care teams in over 95 countries around the world. In 2020, Orbis reimagined in-person Flying Eye Hospital trainings as virtual ones to ensure that eye care teams could still access critical training safely during the pandemic. Orbis reached nine countries in 2020 and 34 countries in 2021 through virtual Flying Eye Hospital projects. As the plane has returned to in-person programming, the virtual model Orbis developed is being used in conjunction with in-person training, a concept known as "blended learning," to ensure that participants can maximize the time with their mentors, continue their education after the plane leaves and more.

Globally, 1.1 billion people live with vision loss, and 90% of cases are completely avoidable. Nine out of ten people with vision loss live in low- and middle-income countries, where quality eye care is often difficult, sometimes impossible, to access. An effective, lasting solution to this challenge is to ensure that eye care professionals in such countries can access quality ophthalmic training, building the skills they need to provide quality eye care to patients in their communities.

Over the past four decades, Orbis has conducted tens of millions of eye screenings and performed eye surgeries and laser treatments for hundreds of thousands of patients. Orbis has also trained hundreds of thousands of eye care professionals at all levels, including tens of thousands of medical doctors. The people Orbis trains go on to provide sight-saving care in their communities and, in many cases, go on to train eye care professionals themselves.

Read more from the original source:
World Sight Day: Orbis, UC Davis team up to train eye care teams from Latin America to fight avoidable blindness - Ophthalmology Times

Read More...

Juan Williams: The GOPs epidemic of intentional blindness – The Hill

October 15th, 2022 1:44 am

Act 1 Intentional blindness?

How else to explain the GOPs reaction last week after a Daily Beast report that Herschel Walker, running for the Senate as an abortion opponent, paid for a woman to have an abortion?

Even as the former football star denied it, Walkers son called him a liar. He has four kids, four different women. Wasnt in the house raising one of them, tweeted Walkers son, Christian. [H]ow dare you lie and act as though youre some moral, Christian, upright man.

The GOP response to this embarrassing elephant in their room was intentional blindness.

Republicans stand with him, said Sen. Rick Scott (R-Fla.), head of the National Republican Senatorial Committee. So much for opposition to abortion if it means losing a Senate seat.

Act 2 More Intentional blindness?

How else to explain the silence among Senate Republicans when former President Trump said Senate Minority Leader Mitch McConnell (R-Ky.) had a death wish, before throwing a racist barb at McConnells wife?

Not one of McConnells Senate colleagues opened their mouths to stand by him and condemn Trump. None opened their eyes to Trumps threat and racism.

Rep. Liz Cheney (R-Wyo.) was a lonely voice among Republicans in Congress, noting that Trumps words could lead to violence against the Republican leader of the Senate. She labeled his attack on McConnells wife absolutely despicable.

Cheney also noted her partys intentional blindness. How it could be that nobody in my party will say thats unacceptable, she asked.

The Wall Street Journals conservative editorial page noticed the chilling GOP silence.

The death wish rhetoric is ugly even by Mr. Trumps standards and deserves to be condemnedIts all too easy to imagine some fanatic taking Mr. Trump seriously and literally, and attempting to kill Mr. McConnell.

Act 3 Intentional blindness is now a pandemic?

Republicans running in the midterms are now required to close their eyes to the nearly two-year-old reality that a Democrat, President Biden, won the 2020 election. Blind eyes are now a sign of party loyalty.

Last week, data and polling website FiveThirtyEight ran a chilling headline: 60 Percent of Americans will have an election denier on the ballot this fall

Out of 552 total Republican nominees running for office, we found 200 who fully denied the legitimacy of the 2020 election. These candidates either clearly stated that the election was stolen from Trump or took legal action to overturn the results, such as voting not to certify election results or joining lawsuits that sought to overturn the election, the sites staff wrote.

Opinion polls put the share of Republican voters who refuse to accept Biden as a legitimate president at around 70 percent.

Similarly, The Washington Post reported last week that a majority of Republican nominees on the ballot this November for the House, Senate and key statewide offices 299 in all have denied or questioned the outcome of the last presidential election.

One politics professor, Larry Jacobs of the University of Minnesota, told the Post that mistrust of elections and the intentional undermining of their legitimacy is a disease that is spreading through our political process and its implications are very profound.

Jacobs thinking is supported by Pew Research polling. In August, Pew found 51 percent of Republicans say they like political leaders who assert [Trump won in 2020] compared with 17 percent who dislike such leaders.

Many of the Republican candidates running on intentional blindness will be sworn in as members of Congress in January 2023. Their presence on Capitol Hill will give more energy to claims of election fraud which have been proven false in courts, by intelligence experts and repeated audits.

Once in Congress, their next act of intentional blindness might be to try and reverse the outcome of the 2024 presidential election if they dont win.

A Yahoo! News/YouGov poll released in late September shows that among self-described Trump voters from 2020, just 33 percent say candidates should agree in advance to accept the results in this falls elections.

Trumps refusal to concede the 2020 election and baseless claims of voter fraud have proven damaging to the GOP in the recent past.

When he introduced the Big Lie about the 2020 election being stolen, it depressed Republican turnout in Senate run-off elections in Georgia two months later. Two Democrats won, costing Republicans the Senate majority.

The final act in this story of Republicans blinding themselves has yet to be written.

In the Hans Christian Andersen fairy tale about a naked king parading through the streets as if he had dazzling clothes, it took a child to get people to open their eyes. He shouted out that the king had no clothes.

Here is hoping that there is a daring child to open Republican eyes.

Juan Williams is an author, and a political analyst for Fox News Channel.

See original here:
Juan Williams: The GOPs epidemic of intentional blindness - The Hill

Read More...

Charles pays tribute to Malawi’s elimination of disease causing blindness – Express & Star

October 15th, 2022 1:44 am

The King has praised Malawi for its remarkable success in eliminating the infectious disease trachoma which causes blindness.

Charles paid tribute to the hard work, dedication and commitment that led to the breakthrough, in a message to the countrys president, Lazarus Chakwera.

The Countess of Wessex is visiting Malawi to celebrate the achievement and has attended a dinner marking the milestone, before joining guests at Malawis national World Sight Day celebrations on Thursday.

The King said in his message: This is a remarkable success, and a true testament to all those whose hard work, dedication and commitment has led to Malawi becoming the first country in Southern Africa to eliminate this devastating, neglected tropical disease as a public health issue.

Tackling avoidable blindness across the Commonwealth was a cause close to the heart of my beloved mother.

Indeed, the Queen Elizabeth Diamond Jubilee Trust, set up in 2012 to create an enduring legacy for her, took the elimination of trachoma as a major part of its mission.

I am particularly proud that Malawi is the first country supported by the Trust to reach the extraordinary milestone of trachoma elimination.

The World Health Organisation (WHO) announced a few weeks ago it had validated Malawis elimination of trachoma as a public health issue, making it the fourth country in WHOs African Region after Ghana (June 2018), Gambia (April 2021) and Togo (May 2022) to achieve this significant milestone.

Sophie is visiting Malawi in her role as a global ambassador for the International Agency for the Prevention of Blindness, and as former vice patron of the Queen Elizabeth Diamond Jubilee Trust.

Charles went on to say: The commitment made by so many Commonwealth leaders at the Malaria and Neglected Tropical Diseases summit in Kigali a few months ago gives me great encouragement that other countries will be inspired by your achievement and, thus, redouble their efforts to eliminate trachoma along with other such diseases.

The rest is here:
Charles pays tribute to Malawi's elimination of disease causing blindness - Express & Star

Read More...

Page 139«..1020..138139140141..150160..»


2025 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick