StemCell Therapy

Pfizer has signed a deal with Ionis affiliate Akcea Therapeutics, to develop a potential blockbuster antisense therapy to treat patients with certain cardiovascular and metabolic diseases including type 2 diabetes.

The terms of the deal give a clue as to Pfizers assessment of the drugs potential: Akcea and Ionis will receive a fairly modest $250 million up front, split between the two companies, and Akcea will settle its $125 million obligation to Ionis in common stock.

But the companies are also eligible to receive development, regulatory and sales milestone payments of up to$1.3 billionand tiered, double-digit royalties on annual worldwide net sales following marketing approval of the drug codenamed AKCEA-ANGPTL3-LRx.

AKCEA-ANGPTL3-LRx is designed to reduce the production of angiopoietin-like protein 3 (ANGPTL3) and is a regulator of triglycerides, cholesterol, glucose, and energy metabolism.

It is currently in a phase 2 study in patients with type 2 diabetes, hypertriglyceridemia, and non-alcoholic steatohepatitis (NASH) indications that could generate substantial sales following approval from regulators.

Akceas antisense drugs work by blocking the action of messenger RNA, which carries instructions to the cell from the DNA to code for a particular protein.

Antisense drugs are made from components such as synthetic strands of DNA, which target a specific RNA sequence and stop it from producing the protein.

Future milestone payments and royalties will be split equally between Akcea and Ionis, and Pfizer will pay for all development and regulatory costs beyond the ongoing phase 2 study.

Before a filing for marketing approval, Akcea has an option to take part in some marketing activities with Pfizer in the US, and some other markets if certain conditions are met.

Akcea already has two antisense therapies approved Tegsedi (inotersen) for the rare disease hereditary transthyretin-related amyloidosis (hATTR) and Waylivra (volanesorsen) for familial chylomicronemia syndrome.

Damien McDevitt, interim chief executive officer at Akcea, said: AKCEA-ANGPTL3-LRxhas the potential to treat people suffering from certain cardiovascular and metabolic diseases.

Given the unmet medical need for this patient population and the broad market potential, we believe Pfizers expertise and breadth of experience in cardiovascular and metabolic diseases makes it well suited to accelerate clinical development of AKCEA-ANGPTL3-LRx, and to deliver it to patients in need of additional therapies for these life threatening diseases.

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Pfizer inks deal with Ionis and Akcea for potential blockbuster diabetes and NASH drug - - pharmaphorum

Two new studies, one surgical, the other medical come to similar conclusions - significant weight loss alters the course of Type 2 diabetes.

In the first study, 867 40 to 69-year-old, patients with new-onset diabetes were randomized into treatment or control groups. Seven hundred thirty had both their weights and HbA1c measured initially and at five years and represented the study group. It was predominately Caucasian (97%), male (61%), and with a BMI of about 34. At the end of 5-years, 30% of patients who lost 10% or more of their body were in remission from diabetes. And the incidence of remission followed the degree of weight loss the kind of dose-response to treatment that suggests underlying physiologic changes. The researchers considered several associated behavioral changes, smoking cessation, less alcohol or caloric intake, fewer fats, more exercise, you know the litany. But with the exception of a small improvement with diminished alcohol intake, none of those changes made a difference it was solely that drop in weight.

"These findings suggest that remission is achievable without intensive lifestyle interventions or extreme calorie restrictions."

Of course, the study has some fine print. First, while a weight loss of this magnitude during the five years achieved this result for some patients, it was more effective earlier in the course of the disease. The more important caveat and one many of us know first-hand, losing that amount of weight and keeping it off is far easier said than done. And that brings us to the second study.

When is a "bug" a feature?

One of the most frequently performed operations in the mid-20th century was a host of procedures for treating peptic ulcers, stomach ulcers. They have been substantially entirely supplanted by medications like ranitidine (Zantac currently under recall). But even though all those different operations on the stomach "cured" the ulcers, many had an adverse side effect, significant weight loss. Innovative surgeons turned that adverse effect, that operative "bug" into an operative benefit with the introduction of bariatric surgery alterations of the GI tract meant to reduce a patient's weight.

There are several operations categorized as bariatric surgery, some designed to diminish the size of the stomach, increasing the onset of satiety and reducing caloric intake; others that re-arrange the GI tract to reduce capacity and alter metabolism. All are associated with significant weight reduction and have been offered to patients who are significantly obese. A new study looks at how patients, with Type 2 diabetes, undergoing bariatric procedures fare for adverse cardiovascular outcomes the usual concerns of heart attacks, strokes, and other problems.

Roughly 2300 patients undergoing bariatric surgery and with a history of Type 2 diabetes were followed for approximately four years and compared with control patients who did not undergo bariatric surgery. An inspection of the two groups suggests that the control patients were at best "similar" rather than the same, so the effect size I am reporting should be taken with a grain of salt. These patients were far more overweight at a BMI of 40 or higher than the previous study. The surgical group had more dyslipidemia and hypertension; the control group more smokers and blacks. The cumulative incidence of all-cause mortality, coronary artery disease, heart failure, cerebrovascular disease (strokes) atrial fibrillation, and nephropathy (kidney disease) were all reduced over the 8-year follow up for the surgical patients as compared to the controls.

But for me, the critical finding is the profound and long-standing weight loss from the surgery, as depicted on the right. These patients not only had remission from diabetes but significant reductions in the need for medications for both hypertension and dyslipidemia.

"We speculate that the lower rate of MACE after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities."

The surgery is not a free ride, as with all procedures, there can and were complications; 0.7 % of patients died within 90 days of surgery (for open-heart surgery that percentage is about 3.7%). Five percent needed open surgical revision, while 16% had revisions of their operation by more non-invasive means. The authors are not suggesting that bariatric surgery be the primary treatment.

What I think is clear is that in well-motivated patients, a 10% weight loss can "reverse" Type 2 diabetes and show significant improvements in many associated cardiovascular diseases. And weight loss, whether or not assisted by bariatric surgery, had a more substantial impact on adverse cardiovascular outcomes than the new generation of medications for diabetes advertised with an "added cardiovascular benefit." The signal from the studies is strong; at least for me, losing a significant amount of your "over" weight is strong medicine.

Source: Behaviour change, weight loss and remission of Type 2 diabetes: a communitybased prospective cohort study Diabetic Medicine DOI:10.1111/dme.14122 and Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity JAMA DOI: 10.1001/jama.2019.14231

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The Weighty Cost of Diabetes - American Council on Science and Health

Type 2 diabetes is a condition which causes the body to lose control of the amount of glucose in the blood. The body doesnt respond to insulin properly and may not produce enough, and this causes blood glucose levels to become too high. If blood glucose levels stay to high, a number of health complications can occur, including kidney failure, nerve damage, heart disease and stroke. So what can you do to prevent the condition and reduce high blood glucose levels?

Simple lifestyle changes can help get a persons blood glucose levels back into the normal range, with one of these changes being to lose weight.

In a new study carried out by the University of Cambridge, nine of 10 people who reduced their body weight by just 10 per cent within five years of being diagnosed with diabetes were able to achieve remission from the condition.

Diabetes remission in people with type 2 diabetes means blood glucose levels are healthy without the need for diabetes medication.

This reinforces the importance of managing ones weight, which can be achieved through changes in diet and increasing physical activity, said Dr Simon Griffin, a University of Cambridge researchers and study senior author.

Previous research has shown people who follow an intensive, low-calorie diet for eight weeks be successful in normalising blood sugar.

But the new study, led by Hajira Dambha-Miller, of the universitys department of public health and primary care, is one of the few demonstrating a less intensive intervention can also be effective in controlling the disease.

Researchers studied data on 867 people aged 40 to 69 who were newly diagnosed with diabetes.

They found 257 participants in the ADDITION-Cambridge clinical trial were in remission from diabetes five years after diagnoses.

Hajira said: Weve known for some time now that its possible to send diabetes into remission using fairly drastic measures such as intensive weight loss programmes and extreme calorie restriction.

These interventions can be very challenging to individuals and difficult to achieve.

But our results suggest that it may be possible to get rid of diabetes, for at least five years, with a more modest weight loss of 10 pre cent.

This will be more motivating and hence more achievable for many people.

Looking at the overall findings, this who lost 10 per cent or more of their body weight within five years of diagnosis were twice as likely to be in remission as those who did not achieve significant weight loss.

Losing this amount of weight was shown to be most effective among newly diagnosed participants.

But it also worked to stabilise blood sugar in around half of people who have had diabetes for a number of years.

Alongside weight loss, drinking a certain drink before bed has also been shown to lower blood sugar.

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Type 2 diabetes: The simple lifestyle change to put the condition in remission - Express

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For people with obesity, a procedure rarely performed in the US more effectively eliminates type 2 diabetes than Roux-en-Y gastric bypass, a small study shows.

Researchers thought that the less common procedurecalled biliopancreatic diversionbetter reduces diabetes because it typically causes greater weight loss than the more common surgery. But in a small study, the researchers found that biliopancreatic diversion appears more effective at eliminating diabetes not just because of greater weight loss but also because the procedure itself seems to make patients more sensitive to insulin.

Our results help explain the high rate of diabetes remission in patients who have biliopancreatic diversion surgery, says senior author Samuel Klein, professor of medicine and nutritional science at Washington University in St. Louis. These data suggest that we should take a closer look to see whether it might be a better option for some bariatric surgery patients.

For the study, published in Cell Metabolism, researchers compared the effects of the two surgeries on insulin and glucose sensitivity in patients who, after their operations, lost 20% of their body weight.

Insulin is the hormone that helps the body keep blood sugar under control. Being more sensitive to insulin allows cells in the body to use glucose in the blood more effectively and helps lower blood sugar.

Roux-en-Y gastric bypass surgery makes a patients stomach smaller by sewing parts of the stomach together to create a pouch about the size of an egg. Surgeons then connect that pouch to the upper section of the small intestine, bypassing a small portion of the upper intestine.

Biliopancreatic diversion is a more complicated surgery. Past studies have found that patients who have the surgery tend to have more postoperative complications.

In this procedure, the surgeon removes the lower part of the stomach, and connects the upper part of the stomach to the end of the small intestine, close to where it empties into the large intestine. Because the procedure bypasses so much of the intestine, the intestine absorbs fewer nutrients from food, putting patients at a higher risk for long-term nutritional deficiencies. So doctors need to closely monitor patients to make sure theyre getting adequate amounts of vitamins and minerals.

The less common procedure, however, results in better blood sugar control and higher rates of diabetes remission than Roux-en-Y gastric bypass surgery. Researchers didnt understand why until, in this study, Kleins team followed 24 patients, half of whom had Roux-en-Y gastric bypass surgery and the other half, biliopancreatic diversion.

The gastric bypass group in the study had average body mass indexes (BMI) of 48. A persons BMI is calculated using weight and height. A higher BMI increases risk of health problems related to weight; a BMI of 30, for example, is considered obese. Those who had biliopancreatic diversion had average BMIs of 56.

Surgeons performed the procedures overseas at Catholic University in Rome because biliopancreatic diversion is more commonly performed in Italy. In the US, surgeons performed some 228,000 bariatric procedures in 2017. Fewer than 3% were biliopancreatic diversion.

After surgery and a 20% loss of body weight, researchers measured the patients metabolic reactions to meals, with close attention paid to glucose levels, sensitivity to insulin, and how much insulin they secreted after eating.

The researchers found no difference in the benefit of surgery-induced weight loss to patients pancreatic function, in terms of insulin secretion, but patients who received biliopancreatic diversion surgery were more sensitive to insulin.

Klein notes that while the patients had obesity, none had a type 2 diabetes diagnosis. Researchers structured the study that way because they wanted to independently measure the insulin sensitivity after a meal, without potential complications caused by diabetes medications.

This study demonstrates that biliopancreatic diversion has unique, beneficial effects on insulin action, independent of any weight loss, he says.

As to whether the findings mean that surgery is preferable, Klein says thats less clear. The main consideration, he says, should be patient safety.

This study demonstrates additional metabolic benefits from biliopancreatic diversion, compared to Roux-en-Y gastric bypass, he says. But the type of bariatric surgery performed on any individual patient depends on many considerations, including an assessment of the effectiveness and safety of the procedure, patient preference, and the surgeons experience.

Klein, chief of the geriatrics and nutritional science division, adds that Roux-en-Y gastric bypass provides considerable benefits in helping people lose weight and in treating type 2 diabetes but does not have the weight-loss-independent benefits on insulin sensitivity of biliopancreatic diversion.

The National Institute of Diabetes and Digestive and Kidney Diseases, the National Heart, Lung and Blood Institute of the National Institutes of Health, and the Pershing Square Foundation suppported the work.

Source: Washington University in St. Louis

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This other bariatric surgery better reduces diabetes - Futurity: Research News

Love Island contestants Theo Campbell and Idris Virgo have been beefing online after Idris accused Theo of faking his blindness in one eye.

Idris posted a screenshot of an argument he was having with Theo on Instagram DM on Twitter.

Theo replied to him with a screenshot of a group chat Idris was allegedly a part of. In this group chat, Idris writes: "Think it's fake tbh" when talking about Theo's partial blindness.

Theo wrote on Twitter: "You missed out the part where youre telling youre little people Im lying about my eye.. only a idiot like yourself would lie about such a thing. And that fact youre putting our convo on Twitter just proves once again what a BEG you are. BEG BEG BEG such a loser."

Theo then also added: "Youre boring. You didnt get an invite to the reunion because you had 0 personality on the show. Everyone else should, only you shouldnt. And because your a puppet thats why you wont get casted again. I duno [sic.] why you try so hard online to make noise. But carry on its laughable. [sic.]"

Idris then replied: "Who are you again? People only know who you are because of your girlfriend other than that youre irrelevant. Man had to shoot him self with a cork to get clout."

Idris Virgo was part of Love Island 2019

Theo went blind in one eye in August, after being hit by a champagne cork at a party in Ibiza.

The accident left him blind in one eye, undergoing surgery and holding out hope of restoring his sight in the eye.

In the aftermath, Kaz, Theo's girlfriend, has been at his side and Josh Denzel was accused of mocking him.

Josh Denzel posted a picture of the "and I ooop" meme with no caption, hours after news broke of Theo's accident, which left him permanently blind in one eye.

Josh later deleted the tweet, however users have been quick to repost screenshots accusing him of making fun of Theo's injury. Kaz has since weighed in on the drama to say Josh has privately messaged them with a "sob story", adding: "Theo couldn't care less."

Watch the moment Theo Campbell got blinded by a champagne cork

Love Islands Theo left blinded in one eye by flying champagne cork

Josh Denzel accused of mocking Theo Campbells blindness on Twitter

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Theo Campbell accused of faking blindness by fellow Love Island contestant - The Tab

Mississippi State Universitys National Research and Training Center on Blindness and Low Vision is hosting an informational event in honor of White Cane Awareness Day Oct. 15. The event is taking place from 10 a.m. to 2 p.m. on the Drill Field and will include booths, an obstacle course and games.

White Cane Awareness Day occurs annually on Oct. 15. According to Kendra Farrow, the NRTCs Research and Training associate, this day is designed to bring awareness to people with blindness and low vision and to teach people about white canes.

While gesturing to her white cane, Farrow explained its significance.

It is a mobility tool that helps the individual who cannot see to know what is in front of them, Farrow said. They can detect surface changes, drop-offs and stairs.

The informational booths will allow people to experience what it is like to have blindness or low vision. According to Emily Damm, the NRTCs communications specialist, visitors can go to the welcome booth to learn about interacting with a person who uses a white cane, the laws regarding white canes and blindness-related professions.

At another booth, visitors can braille their name and interact with an off-duty guide dog. A representative will talk about the importance of braille and how those with blindness and low vision use it to read, Damm said.

Visitors can also put on simulator glasses at the booth. Damm said people can wear glasses or a bandanna while participating in a smell test with different spices. The smell test allows people to see what it would be like to cook in the kitchen with a visual impairment.

We have simulator glasses that show what it would be like to see with Glaucoma or a diabetes condition, Damm said. They can pick out one of these eye conditions to wear or use a bandanna to have complete blindness.

While wearing glasses or a bandanna, visitors can go through an obstacle course that is run by MSU sorority, Delta Gamma. According to Andrea Black, a senior studying biological sciences and the Delta Gamma vice president of Foundation, participants can navigate through a path that contains boxes and other objects.

The course brings an educational opportunity about the world of blindness, but it is still in a fun way, Black said. It allows people to really understand what is going on, but it is not a presentation. People are still having fun while promoting awareness and understanding.

According to Clare Baumhauer, a senior marketing major and the president of Delta Gamma, the sororitys philanthropy is Service for Sight, and they share the same mission as the NRTC. The sorority wants to help educate students on this campus about blindness and visual impairment.

Visitors can also participate in games designed for people with blindness and low vision. According to Damm, participants can play goalball and beep baseball while wearing simulator glasses or a blindfold.

Goalball is a game of goalies versus goalies. The ball has bells attached to it, so the players can locate the ball. In beep baseball, players run between two bases and play with a ball that beeps.

Damm expressed that the NRTC typically works to help individuals who are blind and visually impaired through research, programs and other service providers. She said she is excited to do something different and work with the community through this event.

This is new for us to go directly into the community and have this awareness event, but we felt like the celebration of the white cane aligns perfectly with our mission of providing education to the community, Damm said.

Speaking as a person with blindness, Farrow notices the lack of understanding about blindness and low vision. She experiences people who do not understand her condition and treat her like she is not capable.

Farrow believes this event can allow people to change their mindset and appropriately interact with those who are blind and visually impaired.

If someone loses their vision, it is not the end. There are plenty of activities that a person can do. There are plenty of jobs that a person can do, Farrow said. If someone loses their vision, it is important to have the idea planted in your mind that they can still be a successful person.

Farrow said she hopes NRTC's activities in honor of White Cane Awareness Day serve as an educational opportunity that the community can enjoy.

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MSU's NRTC to host games, obstacle course in honor of White Cane Awareness Day - The Reflector online

Fans cant stop thinking about the This Is Us Season 4 premiere. After introducing a variety of new characters with seemingly no connection to the Pearson family, the writers flipped the switch and revealed how they fit in with the narrative. One of the most shocking revelations was Jack Damon (Blake Stadnik), the adult version of Kate (Chrissy Metz) and Tobys (Chris Sullivan) blind baby boy. Now, This Is Us is back in the present day, where Kate and Toby are learning to raise a blind child. And while some viewers may know Stadnik is visually-impaired in real life, others are questioning if baby Jack is really blind.

In an interview with People, Metz and Sullivan opened up about their characters storyline for This Is Us Season 4. They also shared how baby Jacks blindness will affect them moving forward.

I did learn about how, instead of, of course saying, Oh, look at this, you have to narrate whats going on, Metz told the publication. We sort of take for granted when a child is able to see. Then with a child whos seeing impaired, there are times where people are like, Oh, Jack look at this. You just forget.

Metz then revealed that the baby playing little Jack in This Is Us isnt blind in real life. The real baby is not seeing impaired, the actress explained. So its really about training your mind to narrate, or before something happens, to make sure that youre explaining whats going to happen as to not surprise the baby.

Meanwhile, Sullivan shared what it was like working with the babies. Once we got the hang of it, everything seemed to kind of fall into place. The babies that were working with are great, and theyre actually very easy, he said. Its easier than working with the puppy.

According to the Los Angeles Times, Stadnik is legally blind. He has Stargardt disease, a form of juvenile macular degeneration. And since he first appeared in This Is Us, Stadnik has opened up about his blindness with his fans. When asked if he was blind in real life on Instagram, Stadnik responded graciously.

Its ok to be curious, Stadnik wrote with a smiley emoji. Yes, I am legally blind. I have some vision; enough to get around in my everyday life, but I occasionally use a cane. I also use a number of assistive tech devices to do things like read or use my computer. Thank you for watching the show!

The actor also thanked viewers for their support and noted the importance of representation. Thank you to everyone who has shown me so much love after last nights episode, Stadnik wrote on Instagram. It is a dream come true to be on screen with the incredible cast of This Is Us, and its an enormous honor to represent a low-vision character who is so powerful and nuanced.

Creator Dan Fogelman always knew Kate and Tobys son would be blind, per Entertainment Tonight. So, the This Is Us team began searching for the right actor for the part between seasons three and four.

It was an interesting casting process because we wanted to cast a blind actor, Fogelman said. We had started our casting process very early, even in our off-season. I was looking for a leading man who was without sight and who could be funny, charming, accessible and sweet.

And of course, when they found Stadnik, everything fell into place. One of the wonderful things about our casting department was it wasnt like they only found Blake, Fogelman continued. There were a bunch of really viable, wonderful casting choices that came through our casting department. Blake, when he came to us, was clearly the guy.

Although the babies portraying baby Jack arent visually-impaired, its clear the This Is Us team is trying to be inclusive with Stadniks casting. And since Jack Damon is an adult, who knows? Perhaps fans will one-day meet teenage Jack, represented by another blind actor. But, as of now, only time will tell. So stay tuned.

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'This Is Us': Is Baby Jack Blind in Real Life? - Showbiz Cheat Sheet

Whats your favourite thing to look at? Your dogs face? The most unbelievably Instagrammable pok bowl EVER? A sprawling autumn sunset where the sky is on fire? Now imagine that you know youre going blind: whats the last image you would want to see, the one that would stay with you? Thats the agonising question asked by a new free photography show, Blink, at Oxo Tower, supporting trachoma charity Sightsavers.

Trachoma is a condition that affects nearly 142 million people across the world, many of them children. Its painful, slow, and untreated leads to permanent, total blindness. But its also curable and preventable. Sightsavers is hoping to end the disease for good by 2025.

To highlight the plight of global trachoma sufferers, some world-famous photographers including fashion don Nick Knight have contributed to the show, which runs October 9-13. Each of them has been asked to choose an image of theirsthat they would want to be the last thing they ever saw. But theres a twist. Trachoma is characterised by compulsive blinking, and in Blink created by MET Studio as the viewers stand in front of the images, their normal, natural blinking will be captured by movement technology and gradually make the images degrade and fade until they completely disappear. Its literally blink and youll miss it. So dont miss it.

Blink is at Oxo Gallery, Oxo Tower Wharf, Bargehouse St, SE1 9PH. Tube: London Bridge. Oct 9-13. Free. Find out more here.

Looking for more photography in London? Find out why we gave Tim Walkers V&A show five stars.

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World-famous photographers are part of this interactive show about blindness - Time Out

2020 is a critical year for Orbis International and other leaders in the global eye health community. Next year will mark the end of Vision 2020, a global project of the World Health Organization and the International Agency for the Prevention of Blindness to reduce avoidable blindness.

When the project was launched just over 20 years ago, the number of blind people worldwide then 45 million was expected to double by 2020. Thanks to the coordinated efforts of the global eye health community galvanized by Vision 2020, the doubling never occurred.

Despite this progress, the World Health Organization's first-ever World report on vision, launched today, shows that 2.2 billion people around the world live with vision impairment or blindness. Of those, at least 1 billion people have conditions that could have been prevented or have yet to be treated. The vast majority of this burden is borne by people from low- and middle-income countries, women, older persons and those from rural communities and ethnic minorities.

Experts had already predicted that global blindness and vision impairment are set to triple by 2050 because of population growth, aging and changes in lifestyle. This increase in patient load will result in a tripling of global demand for eye care; already the number of people in need of care is outpacing the number of trained ophthalmologists.

"As 2020 approaches, we have much progress to celebrate, but if we are to prevent the looming crisis, we cannot rest on our laurels," said Bob Ranck, President & CEO of Orbis International. "We have to take what we've learned over the past two decades and use it to make our future efforts laser-focused on what we know will preserve vision for the greatest number of people."

Taking a people-centered approach: Training local eye health teams is the most sustainable way to ensure that vulnerable communities gain long-term access to the quality eye care they need in their communities. 75% of all blindness and visual impairment is treatable or preventable. A lack of access to screening and treatment is the primary barrier keeping hundreds of millions of people living in low- and middle-income countries from saving or restoring their sight.

Going to scale: Leveraging innovation and technology is one of the most cost-effective ways to help local eye health teams improve their quality of patient care. Tools like artificial intelligence, virtual reality and telemedicine have already shown their potential to change the way eye health teams in rural and resource-poor communities conduct screenings for common conditions that endanger vision, and deepen their skills by learning from colleagues around the world. These tools will become even more vital as population rises and patient loads increase.

"We know what needs to be done to avert the looming vision crisis, but it can't be accomplished alone," said Danny Haddad, M.D., Chief of Program at Orbis International. "The achievements made over the past twenty years prove that there is strength in numbers, and collaboration will be key as we continue our fight against avoidable blindness."

Orbis International's contributions to preventing the looming crisis are evident in our recent impact. In 2018 alone:

Learn more about Orbis's impact in our recent report.

About Orbis InternationalOrbis is a leading global non-governmental organization that has been a pioneer in the prevention and treatment of avoidable blindness for over 30 years. Orbis transforms lives by delivering the skills, resources and knowledge needed to deliver accessible quality eye care. Working in collaboration with local partners, including hospitals, universities, government agencies and ministries of health, Orbis provides hands-on ophthalmology training, strengthens healthcare infrastructure and advocates for the prioritization of eye health on public health agendas. Orbis operates the world's only Flying Eye Hospital, a fully accredited ophthalmic teaching hospital on board an MD-10 aircraft, and an award-winning telemedicine platform, Cybersight. To learn more, please visit orbis.org.

Media ContactKristin Taylor Associate Director, Global Marketing and Communications kristin.taylor@orbis.org

SOURCE Orbis International

http://www.orbis.org

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This World Sight Day, Orbis International Calls for All Eyes on 2020 and Preserving the Future of Vision - PRNewswire

(PRESS RELEASE) CHICAGO National non-profit organizations Fight for Sight and Prevent Blindness are announcing a call for applications for the Joanne Angle Public Health Award, a $25,000 grant to support a public health research project seeking to put an end to unnecessary vision loss.

The award was named for Ms. Joanne Angle who served on the National Board of Directors for Prevent Blindness, and both its Government Affairs and Audit committees, in addition to her work with the Association for Research in Vision and Ophthalmology (ARVO).

The deadline for the Fight for Sight-Prevent Blindness Joanne Angle Public Health Award is Friday, Nov. 15, 2019, at 12 p.m. (ET). Applications must be submitted on the Fight for Sight grant portal, https://www.fightforsight.org/Grants/Application/. The recipient will be announced in Spring of 2020.

The Fight for Sight-Prevent Blindness Joanne Angle Public Health Award was established to provide much-needed funding for research investigating public health related to eye health and safety. Applications will be accepted in the following priority areas:

We are proud to join with Fight for Sight to provide financial support to research programs that are working toward our shared goal of ending preventable vision loss, said Jeff Todd, president and CEO of Prevent Blindness. Today, through the Joanne Angle Public Health Award, we continue to support individuals and institutions that are working towards that same mission.

Arthur Makar, Fight for Sights executive director remarked, We are thrilled to be partnering with Prevent Blindness on the Joanne Angle Public Health Award. It is allowing us to expand our grantmaking from traditional scientific research and into the public health arena. We have collaborated with Prevent Blindness unofficially on various projects. This is a lovely way to solidify our relationship.

Past recipients of the Prevent Blindness Joanne Angle Award include Brian J. Song, MD, MPH, at the Massachusetts Eye and Ear, and the Department of Ophthalmology at Harvard Medical School, for his study Glaucoma Detection in Diabetes Teleretinal Programs. And, Rajeev S. Ramchandran, MD, MBA, Associate Professor of Ophthalmology, University of Rochester School of Medicine and Dentistry, for his study, Implementation Science Based Study of Teleophthalmology for Diabetic Retinopathy Surveillance.

For more information on the Fight for Sight-Prevent Blindness Joanne Angle Public Health Award, contact Arthur Makar, FFSs Executive Director, arthur@fightforsight.org.

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Fight For Sight and Prevent Blindness Announce Call for Entries for the 2020 Joanne Angle Public Health Award - InvisionMag

Biotechnology company Phylogica (ASX: PYC) is one step closer to finding a treatment for the leading cause of childhood blindness, achieving a major milestone in its human retina in a dish study.

The company today reported results from its flagship drug program, in which its proprietary drug delivery technology was used on a 3D model of a retina created from human stem cells.

According to Phylogica, the study achieved greater than 90% effectiveness after a single dose.

Phylogica chief executive officer Dr Rohan Hockings said the success of the study is an important milestone for the company as it materially increases the probability that its flagship drug program will prove effective in human studies.

The results also complement Phylogicas earlier outcomes in animal models and functional studies in human cells with the targeted disease, retinitis pigmentosa.

Retinitis pigmentosa is a genetic degenerative eye disease that is considered to be the leading cause of childhood blindness.

It affects between 4,000-8,000 people in the western world and is estimated to be a $1 billion per annum market. There are currently no treatment options for the disease.

The company is very excited by the result of this study given its implications for our objective of taking a treatment to market, Dr Hockings said.

In summary, Phylogicas drug program for treating retinitis pigmentosa has now shown highly effective delivery in animal models with sustained duration of effect; the ability to reverse the disease process in human cells; highly effective outcomes in complex models of the human eye; and a favourable proof of concept toxicity profile.

Phylogicas next aim is to seek validation of its latest results across multiple patients with different genetic mutations in the same retina in a dish models.

This will allow the company to begin investigational new drug enabling studies, including large animal toxicology studies, before progressing to human clinical trials.

By afternoon trade, Phylogica shares were sitting 8.51% higher at $0.051.

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Phylogica achieves milestone in drug study aimed at treating childhood blindness - Small Caps

Visual acuity testing during a rapid assessment of avoidable blindness in Mexico. Photo by: Sarah Polack / International Centre for Eye Health/ CC BY-NC

MANILA Population growth and aging are fast outpacing reductions made in the prevalence of visual impairment over the past three decades, according to the World Health Organizations first-ever report on vision published Tuesday.

At least 2.2 billion people are currently estimated to be suffering from a form of vision impairment or blindness globally. The number of people with myopia, an eye condition that makes it difficult for a person to see distant objects, is expected to increase from the estimated 1.95 billion people in 2010 to 3.36 billion people by 2030, according to the report. People in need of yearly or biennial retinal examination for diabetic retinopathy will increase by 50% in 2040.

A bolder vision for eye care

As a two-decade push to end blindness by 2020 draws to a close, advocates indicate the goal is unlikely to be met. In hindsight, they admit they could have framed the goal better. Going forward, bold action is needed.

The anticipated rise in the numbers of people suffering from different forms of visual impairments and at-risk of blindness is expected to pose challenges to countries health systems, which are already constrained in reaching all affected populations and providing quality interventions.

Although increases in cataract surgical rates have been documented in many countries, recent evidence suggests that post-operative vision results are, at times, suboptimal, the report states.

If eye care services are integrated in countries national health systems, we stand a better chance of making sure that people can access the health services that they need across the course of their lives.

People living in rural areas, women, the elderly, people with disabilities, ethnic minorities, and refugees often burdened with higher rates of vision impairment and blindness are also often unable to access eye care services. One issue is that eye care services are often restricted to urban and larger regional settings.

One-third of countries that completed WHOs eye care service assessment tool in 2014-2016 also revealed equity gaps in the distribution of health care workers specializing in eye care across countries geographic areas. In some of these countries, optometry is not recognized as a profession.

A number of countries health insurance schemes dont provide coverage for eye-related medicines and interventions such as cataract surgery. The cost of these interventions often comes out of patients own money.

Where patients are covered, the challenge is accommodating the increase in the number of surgical interventions while ensuring benefits are not taken advantage of by schemes.

In the Philippines, PhilHealth, which oversees the countrys public health insurance scheme, limited the number of cataract surgical procedures per accredited surgeon to 50 per month after reports emerged in 2015 of fraudulent schemes by providers who prioritize profit over need for surgery.

But one of the biggest challenges is lack of data. Without it, it would be difficult for decision-makers and implementers to identify the problems and provide targeted solutions, as well as make the case for resource allocation.

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As the report itself states, more reliable data on the met and unmet eye care needs is required for planning eye care services, so we can identify who needs eye care services, who is not currently accessing them and where they are located, said Dominic Haslam, director of policy and program strategy atSightsavers, an international charity working to address avoidable blindness and other disabilities.

In many of the countries where international NGOs work however, health management information systems are still being developed. Haslam said efforts to strengthen health systems should extend to these vital information systems, and include eye health data.

Over the next few years, WHO is planning to publish a suite of tools to help countries develop comprehensive eye care services and we look forward to supporting this in the countries where we work, he said.

The report underlined the importance of integration in addressing the burden of eye conditions. It recommends countries integrate eye care in their national health plans and care packages and services. It also underscored the importance of coordination between the public and private sectors.

Every country has a health and strategic plan, but eye care is frequently not seen as an integral part of it. The eye care agenda has been frequently planned and delivered as in a parallel system and not as an integral part of health, said Alarcos Cieza, coordinator of blindness and deafness prevention at WHO, in a Devex interviewlast July.

Also, in many countries, a high percentage of eye care services are delivered by the private sector, and usually the public and private sectors are not well coordinated, she added.

Haslam hopes the report will galvanize governments to action, and lead to greater awareness and the political will to deliver better eye health for all.

If eye care services are integrated in countries national health systems, we stand a better chance of making sure that people can access the health services that they need across the course of their lives, he said.

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Aging and population growth, challenges for vision care: WHO report - Devex

Credit: nters for Disease Control and Prevention

Above: This 1975 file microscope image made available by the Centers for Disease Control and Prevention shows chlamydia trachomatis bacteria magnified 200 times.

The number of cases of three major sexually transmitted diseases in California reached a 30-year high in 2018, according to a state report released Tuesday.

More than 336,000 cases of chlamydia, gonorrhea and syphilis were reported last year, as rates of all three STDs continued to increase across the state, the California Department of Public Health reported.

Officials said they are particularly concerned by the number of congenital syphilis cases, which were 14% higher than the previous year and nearly 900% higher than in 2012.

There were 22 stillbirths or neonatal deaths because of syphilis last year, the report said.

If left untreated, syphilis can result in blindness, hearing loss and neurological problems. Chlamydia and gonorrhea can lead to infertility, ectopic pregnancy and chronic pelvic pain.

Many STDs can be cured with antibiotics.

The highest rates of STDs are among young people ages 15 to 24, officials said.

The department's acting director, Dr. Charity Dean, urged sexually active people to use condoms and get tested.

"Regular testing and treatment are essential prevention strategies, even for people who have no symptoms," Dean said in a statement. "Most people infected with an STD do not know it."

State officials are collaborating with local agencies to coordinate efforts to control STDs, the health department said.

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Cases Of STDs Reach 30-Year High In California - KPBS

MORGANTOWN Genes borrowed from a spider turned Peter Parker into Spiderman. If scientists can use archaea tiny organisms similar to bacteria as a source of useful genes for humans, might it help prevent blindness one day?

West Virginia University researcher Maxim Sokolov and his colleagues have received $1.5 million from the National Institutes of Health to study the biochemistry that might make it possible.

I recently watched Spiderman again, Sokolov said. Remember, in Spiderman, Peter Parker was bitten by a spider, the spider gave him some of its DNA and he got the traits he didnt have before. We had the same idea.

Only instead of combining spider and human DNA, Sokolov and his team including WVU researcher David Smith will add archaeal DNA to mouse models genes. Then theyll assess whether the mouse models gain the superpower of resisting retinal degeneration.

Archaea are microscopic, single-celled organisms that populate diverse habitats, from the hydrothermal waters of Yellowstone National Park to our very own guts. Unlike mammals and other complex life forms, archaea produce special proteins in their cells called molecular chaperones that help them to survive in the harsh environment.

Generally speaking, molecular chaperones guide other proteins through the folding process. They embrace the baby proteins and help them to fold correctly, said Sokolov, an associate professor in the School of Medicines Departments of , Biochemistry and Neuroscience. And if the baby proteins fold incorrectly, the chaperones will unfold them and say, Fold again.

In this sense, they act like janitors that purge the cells of aberrant proteins.

Avoiding and getting rid of misfolded proteins is crucial. If they accumulate in a cell, they can lead to serious problems. Specifically, a pileup of misfolded proteins in our eyes photoreceptors, due to certain mutations, will slowly kill the photoreceptors and cause blindness.

To counteract these effects, Sokolov and his team will use archaeal genes to instruct cells to make archaeal molecular chaperones. According to the researchers earlier work, doing so will prompt mouse cells to produce chaperones they would never make naturally.

You bypass evolution, Sokolov said. All of a sudden, this chaperone thats not present in mammals not just mice but mammals is there. But you dont know what will happen. This is where you start to do research.

The team will determine if and how the archaeal chaperones protect the mouse models photoreceptors from the harmful effects of misfolded proteins.

Theyll also investigate how well the intervention thwarts retinal degeneration caused by several mutations linked to the development of blindness in humans.

What they discover could suggest new methods to prevent incurable eye diseases, including retinitis pigmentosa, a genetic disorder that causes irreversible vision loss. But their findings may also have broader implications.

There are diseases in the brain, and there is this disease called aging said Sokolov. Weve used the eye as the model, but Ill be interested to look much, much wider than that.

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Bypassing evolution: researcher studies gene modulation to prevent blindness - Hampshire Review

Video advertising is now dominating the digital advertising market. According to the International Advertising Bureau (IAB), ad spends on digital video continue to accelerate. Marketers report an increase for digital video budgets by 25 per cent year-on-year. Digital video is expected to have the fastest growth, with CAGR of 37 per cent that will touch Rs. 5,545 crore by 2021. The reasons are obvious in videos, stories and emotions can be communicated very well and user engagement is higher than in other advertising formats.

The dictation of distribution

The downside of the boom is that we are now flooded with videos across websites and platforms. Videos are constantly popping up on social networks, on video platforms or on publisher pages, or in the form of pre-rolls, forcing us to look at an advertising message before we can finally consume the content we have chosen.

This unrestricted projection of video content upon unsuspecting consumers has given rise to a phenomenon called 'Video Blindness. Users ignore the video and the advertised brand. According to a recent study by Magna, users skip video ads on YouTube automatically when they have the option, without paying attention to the brand or the content. On an average, users in Germany skip an ad after just 2.3 seconds.

Many advertisers are heavily influenced by these metrics when designing their video ads. You can see the logo right at the start and the video comes to a climax within the first few seconds.

In addition, the same videos are simply scattered on different platforms in different formats. For example, TV spots are subtitled in the social feed, and videos several minutes long appear as a pre-roll with the hope that the user will not click on Skip Ad. But is this really the way a brand wants to present itself and how videos should be consumed?

Seen vs. visible videos

Brands are thus guided by distribution formats, without questioning if the distribution mechanism really benefits the user and the brand. It seems that the mistakes of banner advertising from the previous decade are now repeated in video advertising visibility at any price regardless of user experience.

But what does viewability in video advertising mean? Internationally, the IAB's 50/2 rule on video usually applies 50 per cent of a video's pixel count must be visible in the user's visible area for at least two seconds. What makes sense in banners (where rule 50/1 applies), as it is relatively easy to capture a banner message is more than problematic in a 60-second video.

A video can thus achieve many thousands of views without being really noticed by a significant target group. A division between real views, where users really focus on video, and visible ads is imperative to getting real metrics.

What can we do?

Some sensible adjustments can significantly increase the results and effectiveness of video campaigns.

Analyse KPIs accurately KPIs should not be rigidly selected and analysed equally for all channels. A non-skippable pre-roll will inevitably result in a very high completion rate. For autoplay formats, if possible, a more sophisticated definition of a view than 50/2 should be agreed upon.

Plan Additional Engagement A very good measure of the effectiveness of a campaign is the engagement that comes after the video. A call-to-action, such as a link that leads to a landing page, for example, shows whether:

The right audience has been reached,

The videos were really viewed and not just visible,

Pre-Rolls have really taken care of interest,

The ROI of the measures is really true.

Choosing Proper Distribution Channels The boom in video advertising has led to a wide range of providers. YouTube and Facebook may be the standards. Not to be underestimated are publishers who guarantee a secure and high-quality environment. They can be booked directly or via platforms.

Choose the appropriate formats Pre-Rolls, Autoplay, Click-to-Watch, Stories or Streams: different formats are suitable for achieving different goals. Brands should first define the goals and then choose the right formats for their purposes.

Be careful when recycling Reusing a TV spot on Facebook is certainly very easy, but often not very effective if the video is then played on smartphone screens without sound. These ads have to work well without sound. The videos must be adapted to channels and formats.

The focussed users

Brands should be very interested in reaching people who really care about their brand and products. They should be concerned with real views, not just visibility. Only then can they achieve real commitment and achieve business goals.

Video advertising has the chance to not suffer the same fate as display advertising, and to cure 'video blindness'. Providers such as marketers must finally remember the principles of good marketing inspire users with exciting topics and emotional videos and not overwhelm them with videos on every single page they visit on the Internet.

The author is the head of Outbrain (India), a web advertising platform.

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Video blindness: the reality of skippable ads - afaqs

- A 20-year-old visually impaired girl, Adebayo Balqis, has narrated why she ventured into hairdressing business

- Balqis said she started the business after surviving the ailment that led to her blindness

- The young entrepreneur also noted that she uses the money she earns to cater for her education

Adebayo Baliqis is a 20-year-old visually impaired young Nigerian who defied all odds to turn her disability to ability through hairdressing skills.

Legit.ng's regional reporter in Oyo, Imran Khalid, reports that Balqis, who hails from Isale Abudu, Saki, in Saki West local government area of Oyo state, got many surprised as she makes earnings to cater for her education and well-being through hairdressing, making of sweet and popcorn.

It was gathered that Balqis, who is currently in SSS 1 at Awoyemi commercial high school, Okeho, in Kajola local government area of the state, took on the business of hair platting and other commercial engagements after her parents had spent all what they had on the ailment that eventually resulted to her blindness.

A 20-year-old visually impaired Adebayo Baliqis platting one of her customers' hair. Credit: Imran KhalidSource: Original

Baliqis' hardwork has made people to celebrate and tag her 'Omolakanda' who despite her predicament, does not take to the street for begging or get involved in illicit dealings.

Speaking with Legit.ng in her hostel on Tuesday, October 8, Balqis said her current blindness had not made her to despair or be discouraged, saying that she became more motivated by her situation.

She noted that her skills of hair platting was discovered as a result of pressure from her father who said she must learn how to plate hair, adding that she ventured into business and other commercial engagements after the sickness took away her sight.

"I have been doing all the businesses so as to raise money for my well-being and acquisition of sound education," she said.

A 20-year-old visually impaired Adebayo Baliqis attending to one of her customers. Credit: Imran KhalidSource: Original

She said having known the financial challenges of her parents, she ventured into all commercial engagements so as to make life easier for herself.

Baliqis, a devout Muslim, called on well-meaning Nigerians to come to her aid and support her with equipment and materials that could raise her up in business of hair platting, making of popcorn.

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Meanwhile, Legit.ng had previously reported that the LA Basic school for the handicapped, located in Okeho area of Oyo state, showcased pupils with disability with most outstanding and unique qualities and skills.

NAIJ.com (naija.ng) -> Legit.ng We have upgraded to serve you better

I want to build a television set -13-yr-old aspiring engineer | - on Legit TV

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Meet 20-year-old visually impaired girl who engages in hairdressing to cater for her education (photos) - Latest News in Nigeria & Breaking Naija...

Optical illusions can use colour, light and patterns to create images which can be deceptive or misleading to our brains.

The information gathered by the eye is then processed by the brain, creating a perception that in reality, does not match the true image.

Which is why Lenstore , the masterminds behind a number of Pac-Mac optical illusion , have shared yet another mind-boggling brainteaser for people to get their heads around.

The motion blindness illusion will leave you scratching your head for days can you really see what's going on?

To understand what is going on, first start by focusing on the red and green flashing dot in the middle of the spinning blue grid.

You should find that the three non-flashing dots around it will begin to disappear sporadically sometimes one or two at a time, or all three simultaneously.

Then you will see that the illusion works because of "motion-induced blindness".

Motion-induced blindness (MIB) is a phenomenon of visual disappearance or perceptual illusions observed in the lab, in which stationary visual stimuli disappear as if erased in front of an observer's eyes when masked with a moving background.

Meanwhile, this isn't the only optical illusion to baffle the internet in recent weeks.

Previously, Lenstore unveiled the Pac-Mac optical illusion which is seriously confusing.

According to the website, focus on the cross in the centre of the red circles popping in and out of sight.

You will find that space in the red circles leave behind are replaced by green spot afterimages.

After a while, you might find that the red spots seem to disappear altogether (due to Troxler's fading).

Troxler's fading is an optical illusion affecting visual perception.

When one fixates on a point for a short time, an unchanging stimulus away from the point will fade away and disappear.

You will find a great example of Troxler's fading when you look at this optical illusion as something very odd happens when you stare at it for 30 seconds .

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Optical illusion with motion blindness goes viral can you see what's going on? - Daily Star

EAST HANOVER, N.J., Oct. 8, 2019 /PRNewswire/ -- Novartis today announced that the U.S. Food and Drug Administration (FDA) approved BEOVU (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD)1. BEOVU is the first FDA-approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase1 with uncompromised efficacy.

Experience the interactive Multichannel News Release here:https://www.multivu.com/players/English/8554151-novartis-beovu-brolucizumab-fda-approval/

"BEOVU meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid," said Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of the HAWK clinical trial. "With BEOVU, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD."

The approval of BEOVU was based on findings from the Phase III HAWK and HARRIER clinical trials, in which BEOVU demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one (week 48)1,2. In both clinical trials, approximately 30% of patients gained at least 15 letters at year one1,2. In HAWK and HARRIER, BEOVU showed greater reduction in central subfield thickness (CST) as early as week 16 and at year one, and fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF)2. Retinal fluid is a key marker of disease activity6.

Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision7,8. Fluid that leaks out of these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula8-10. The BEOVU molecule is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs2. By inhibiting VEGF, BEOVU suppresses the growth of abnormal blood vessels and the potential for fluid leakage into the retina2.

"The approval of BEOVU delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment," said Marie-France Tschudin, President, Novartis Pharmaceuticals. "The product labels of existing treatments state that they are not as effective when dosed every 12 weeks. BEOVU is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what's important in their lives."

In HAWK and HARRIER, eligible patients could be maintained on a three-month dosing interval immediately after the loading phase1,2. At year one, over half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER)1,2. The remaining patients in the study were treated on a two-month dosing schedule1,2.

BEOVU exhibited an overall safety profile comparable to aflibercept. BEOVU is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or with known hypersensitivity to brolucizumab or any of the excipients in BEOVU1. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema or severe intraocular inflammation1.

The most common adverse events (5% of patients) with BEOVU were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain1,2.

Wet AMD distorts central vision and ultimately causes blindness and loss of independence11,12. Estimates suggest that in 2020, 1.75 million people in the U.S. will be living with wet AMD13-15, making it a growing public health concern. Early symptoms of wet AMD include blurry or wavy vision8. As the disease progresses, patients lose central vision so it becomes difficult to see objects directly in front of them8.

"As sight disappears, so does a person's connection to the world," said Dawn Prall, Founder and Executive Director, The Support Sight Foundation. "We welcome a new treatment that helps maintain vision and has the potential for quarterly treatments, which can reduce the burden on patients and their caregivers and help people with wet AMD keep doing what they love with the people they love."

With this approval, Novartis is offering BEOVU Your Way in the U.S. This program provides personalized, one-on-one support for patients and caregivers, with access to a care specialist committed to understanding patients' unique needs and preferences. Novartis is proud to be partnering with patient advocacy organizations to deliver educational materials for patients and caregivers, with the goal of empowering wet AMD patients to live safely and independently.

About BEOVU (brolucizumab-dbll)

BEOVU (brolucizumab-dbll) is the most clinically advanced humanized single-chain antibody fragment (scFv)2,16. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics16-18.

The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms17. BEOVU is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs2,16. In preclinical studies, BEOVU inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction17-19. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema20. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability20.

About the HAWK and HARRIER studies

With more than 1,800 patients across nearly 400 centers worldwide, HAWK (NCT02307682) and HARRIER (NCT02434328) are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 using an innovative q12w/q8w regimen, with a majority of patients on q12w immediately following the loading phase2. Both studies are 96-week prospective, randomized, double-masked multi-center studies and part of the Phase III clinical development of BEOVU2. The studies were designed to compare the efficacy and safety of intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in patients with wet AMD2.

About wet age-related macular degeneration

Wet AMD is a leading cause of severe vision loss and legal blindness in people over the age of 65 in North America, Europe, Australia and Asia, impacting an estimated 20 million people worldwide4,5,11. It is estimated that 1.75 million people in the U.S. will be living with wet AMD in 202013-15. Wet AMD occurs when abnormal blood vessels form underneath the macula, the area of the retina responsible for sharp, central vision8-10. These blood vessels are fragile and leak fluid, disrupting the normal retinal architecture and ultimately causing damage to the macula8-10.

Early symptoms of wet AMD include distorted vision (or metamorphopsia) and difficulties seeing objects clearly8,21. Prompt diagnosis and intervention are essential10. As the disease progresses, cell damage increases, further reducing vision quality8. This progression can lead to a complete loss of central vision, leaving the patient unable to read, drive or recognize familiar faces and potentially depriving them of their independence8,12. Without treatment, vision can rapidly deteriorate22.

About Novartis in ophthalmology

At Novartis, our mission is to discover new ways to improve and extend people's lives. In ophthalmology, we develop and deliver life-changing medicines and therapies for diseases and conditions from front to back of the eye, enabled by data and transformative technologies. Our ophthalmic solutions reach more than 150M people per year, from premature infants to the elderly.

INDICATIONS AND USAGE

BEOVU (brolucizumab-dbll) injection is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BEOVU is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or known hypersensitivity to brolucizumab or any of the excipients in BEOVU. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachments

Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Increase in Intraocular Pressure

Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection including with BEOVU. Sustained IOP increases have also been reported. Both IOP and perfusion of the optic nerve head must be monitored and managed appropriately.

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the BEOVU clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The ATE rate in the two controlled 96-week neovascular AMD studies (HAWK and HARRIER) during the first 96-weeks was 4.5% (33 of 730) in the pooled brolucizumab arms compared with 4.7% (34 of 730) in the pooled aflibercept arms.

ADVERSE REACTIONS

Serious adverse reactions including endophthalmitis, retinal detachment, increases in intraocular pressure, and arterial thromboembolic events have occurred following intravitreal injections with BEOVU.

The most common adverse events (5% of patients) with BEOVU were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with BEOVU. Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 52% of treatment naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 67% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU. The significance of anti-brolucizumab antibodies on the clinical effectiveness and safety of BEOVU is not known.

Please see full Prescribing Information.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Novartis Pharmaceuticals Corporation, a U.S. affiliate of Novartis, is located in East Hanover, NJ. Find out more at http://www.novartis.com.

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Novartis receives FDA approval for BEOVU, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept - BioSpace

Filmmaker Cole Sax wants to introduce audiences to Joanaly Laniohan and her husband, Virgilio, who live in the Philippines.

Cataracts had rendered Joanaly blind for two years, and Virgilio had added the role of his wifes caretaker to being the familys provider until the opportunity came for a free and simple surgery that could restore Joanalys sight.

Sax, who graduated from Park City High School in 2011, will tell the Laniohans story when he screens his new documentary short, Second Sight, at 6 p.m. on Thursday, Oct. 10, in honor of World Sight Day, at the Broadway Centre Cinemas in Salt Lake City. The 30-minute screening, presented by the Salt Lake Film Societys MAST program, is free and open to the public.

MAST (Media Accellerator Studio), is a nonprofit program founded by Salt Lake Film Societys CEO Tori A. Baker and Miles Romney, a Tony-winning Broadway fundraiser and co-producer, that develops artists into entrepreneurs.

I think its pretty relatable that someone would do anything to care for someone they love Cole Sax, Second Sight fillmmaker

The idea to make Second Sight came from Saxs childhood, when he was introduced to vision health by Park City opthamologist Dr. Jeffrey Tabin, who travels around the globe to stop unnecessary blindness caused by cataracts with his nonprofit, The Himalayan Cataract Project.

Cataract blindness affects nearly 40 million people around the world and is brought on by malnutrition and overexposure to sunlight, according to Sax.

For those in developing countries it is a death sentence, taking people out of work and causing a significant decrease in life expectancy, he said. I knew it was a story I wanted to share at some point.

After graduating high school, Sax studied film at the University of Utah and secured a job in the local filmmaking industry. Nearly three years ago, Sax and his friends learned of film grants offerd by Musicbed, a licensing and production company, and began brainstorming ideas.

Inspired by Dr. Tabins work, we decided to do a documentary that would focus on one persons journey of trying to understand what they have and learning about the free 10-minute surgeries that would make it possible for them to see again within 24 hours, Sax said. It was a powerful story and pretty straightforward and we submitted it to the initiative.

Their idea was selected out of 6,000 submissions.

We were given the grant, and they provided us with a bunch of gear, Sax said. But to make the film we wanted to make, we needed to make more money. So we hunted for a nonprofit to come onboard to help budget-wise and to help promote the film.

Sax and his group connected with See International, a nonprofit that works in over 40 countries, where it has provided more than half a million sight-restoring surgeries.

They came on board and gave us all the access we needed, and we ended up going to the Philippines to film our movie, Sax said.

Sax and his crew met the Laniohans from a list of 60 other families. After Sax met with the Lahioans, he found his story.

She had been blind for two years, and I felt I could also put myself in the shoes of her husband Virgilio, who had to become the caretaker, he said. I think its pretty relatable that someone would do anything to care for someone they love.

Sax and his crew shot the film over nine days last October and finished editing it this March.

After completing the film, Sax decided to build a digital website, secondsight.seeintl.org, where the film could live and garner some new donors and support.

If people cant attend Thursdays screening, they can watch the film on the website and learn about the issue, he said.

Sax said one of the biggest challenges of making Second Sight was making a quality and thought-provoking film that focused on his subjects plight.

You want to be sensitive to their story and their journey, he said. We also had a responsibility to be authentic, because we asked people to invest in our film. So we were committed to deliver something that those who gave us grants and donated money would be equally proud of.

Upon release a few months ago, Second Sight was selected for a string of 2019 festivals including Hollyshorts, Rhode Island International Film Festival, DC Shorts and the Hawaii International Film Festival, to name a few.

Its rewarding to have an audience for the project to get people to understand what the experience has been like for this family, let alone millions of people with cataracts worldwide, Sax said. There has been a positive response and people feel connected to the characters in the film, and to me that is powerful, especially if they want to get involved in some capacity or get involved in a larger project.

Second Sight is one of Saxs more personal films, because of his own experience with sight issues.

During high school, I noticed a bunch of black specks in my vision, and after I went to opthamologist, I was told I had eye floaters, which is very common, he said. Then after shooting in the Philippines, I noticed I had a hard time focusing on the monitor for long periods of time, and I was getting sensitive to light.

Sax got his eyes checked and was informed he had intermediate uveitis, an autoimmune disease in the eye.

They told me there was a lot of scar tissue that had built up, but that the uveitis was dormant, which it has been for a few months, now, he said. So in a way, Ive come full circle with this film and my personal life.

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Park City High alumnus Cole Sax creates 'Second Sight' and will screen his film in Salt Lake City - The Park Record

Photo: Depositphotos.com

Researchers at Eindhoven University have been given a 2.9m grant for their work on the development of artificial wombs for premature babies,

The grant, from the EUs Horizon fund, comes a year after the artificial womb concept was first presented at Dutch Design Week. The grant, the researchers say, will make it possible to produce a working prototype within five years.

The artificial womb will act as both incubator and artificial respirator but, the researchers say, its more natural because it resembles a real womb more closely.

Our goal with the artificial womb is to help extremely premature babies get through the critical period of 24 to 28 weeks, says Guid Oei, gynecologist at MMC and part-time professor at the university.

The chances of survival for these babies are low; approximately half of the babies that are born at 24 weeks die. And the ones that survive often suffer from lifelong chronic disorders such as brain damage, respiratory problems and eye conditions that can possibly cause blindness.

Different technologies will be used in developing the womb, says Frans van de Vosse, project coordinator and professor of cardiovascular biomechanics.

The system, he said, will continually monitors the babys condition. Think of heart rate and oxygen supply, but also of brain and muscle activity, he said. Smart computer models that simulate the babys condition provide the doctor with immediate support in the decision-making process with regard to the artificial wombs settings.

University researchers also also developing a practice doll that can accurately simulate extremely premature babies in an intensive care ward. This, the team says, will make it possible to evaluate the artificial womb in a realistic test setting before it is used in clinics.

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EU boost for Eindhoven artificial womb project, prototype in five years - DutchNews.nl