StemCell Therapy

Bank of America (BAC) was the latest major bank to issue a recession shock warning two weeks after the Treasury yield curve inverted. Economists at the Bank of America expect inflation to worsen as the Russia-Ukraine war drags out, while the interest rate shock is just beginning to set in. Because the Fed is expected to remain aggressively hawkish for the foreseeable future to control the 40-year-high inflation rates, the U.S. is currently on recession watch.

Thanks to the inelastic demand for healthcare products, investing in healthcare stocks can hedge some of the markets risks. Furthermore, only 66.4% of the total population have received at least one COVID-19 vaccine dose. As economies collectively push to accelerate the global vaccination drive, healthcare companies with COVID-19 vaccines in their portfolios are expected to benefit from the robust global demand.

Given this backdrop, we believe fundamentally strong healthcare companies Pfizer Inc. (PFE), Johnson & Johnson (JNJ), AbbVie Inc. (ABBV), Eli Lilly and Company (LLY), and Merck & Co., Inc. (MRK) are expected to grow substantially even during a recession. Thus, investing in these stocks now could hedge ones portfolio against the forthcoming potential recession.

Click here to checkout our Healthcare Sector Report for 2022

Pfizer Inc. (PFE)

New York City-based PFE specializes in biopharmaceutical products globally. Its portfolio includes medicines and vaccines served to wholesalers, retailers, healthcare providers, government agencies, pharmacies, and local communities.

On April 4, PFE agreed to acquire ReViral for up to $525 million. With this acquisition, the company would strengthen its capabilities in treating RSV disease and expand its anti-infective pipeline further.

On March 29, the FDA expanded emergency use authorization of COVID-19 vaccine booster in adults aged 50 years and older and authorized a second booster dose for individuals 12 years of age and older who have received the first shot. The second booster dose offers increased protection against severe disease and hospitalization.

Also last month, PFE announced positive results from a yearlong phase 3 trial of etrasimod, which is expected to be a best-in-class therapy in treating ulcerative colitis (UC).

PFEs revenue increased 105% year-over-year to $23.84 billion in its fiscal fourth quarter (ended December 31). Its net income grew 300.6% from its year-ago value to $3.39 billion, while its income from continuing operations improved 464.4% year-over-year to $3.58 billion over the period. The companys non-GAAP EPS increased 151.2% from the year-ago value to $1.08.

The $1.57 consensus EPS estimate for its fiscal first quarter (ended March 31, 2022) represents a 68.3% improvement year-over-year. The $24.55 billion consensus revenue estimate for the to-be-reported quarter indicates a 68.4% increase from the same period last year. The company has an excellent earnings surprise history; it surpassed the consensus EPS estimates in each of the trailing four quarters.

Over the past year, the stock has gained 50.7% in price to close its last trading day at $55.17.

PFEs POWR Ratings reflect this promising outlook. The company has an overall A rating, which translates to Strong Buy in our proprietary rating system. The POWR Ratings assess stocks by 118 distinct factors, each with its own weighting.

It has a B grade for Value, Growth, and Quality. Among the 174 stocks in the Medical Pharmaceuticals industry, it is ranked #14. Click here to see the additional POWR ratings of PFE for Momentum, Sentiment, and Stability.

Johnson & Johnson (JNJ)

JNJ in New Brunswick, N.J., is engaged in the research and development, manufacturing, and selling of healthcare products that are primarily focused on human health and well-being. The company operates through three segments: Consumer; Pharmaceutical; and Medical Devices. It offers its products to the public, retail outlets and distributors, wholesalers, hospitals, and healthcare professionals.

On March 14, JNJ was named in Fortune Worlds Most Admired Companies list for the 20th consecutive year. In addition, it was also ranked #1 on the Pharmaceutical Industry list for the ninth year in a row. These honors are indicative of JNJs unwavering commitment and strong performance within the industry.

On January 6, JNJ announced that based on the largest study in the U.S., a single shot of the JNJ vaccine demonstrated long-lasting protection for up to six months against COVID-19 breakthrough infections, hospitalizations, and ICU admissions. Given the resurgence of COVID-19 cases of late, the vaccine is expected to remain in demand globally.

On December 30, the company announced that the booster shot of the JNJ COVID-19 vaccine reduced the risk of hospitalization among healthcare workers in South Africa when Omicron was dominant, representing 85% of effectiveness.

During its fiscal 2021 fourth quarter (ended Dec. 31, 2021), JNJs net sales increased 10.4% year-over-year to $24.8 billion. Its gross profit rose 14.9% from its year-ago value to $16.85 billion. Its non-GAAP net earnings grew 14.4% from the same period last year to $5.68 billion, while its adjusted EPS came in at $2.13, representing a 14.5% increase year-over-year.

Analysts expect JNJs revenues to increase 6% year-over-year to $23.65 billion in the fiscal first quarter (ended March 31, 2022). Its EPS is expected to increase 0.4% to $2.60 in the about-to-be-reported quarter. It is no surprise that the company has surpassed the consensus EPS estimates in each of the trailing four quarters, which is excellent.

The stock has gained 13.2% in price over the past six months to close Fridays trading session at $182.12.

JNJs strong fundamentals are reflected in its POWR Ratings. The stock has an overall A rating, which equates to a Strong Buy in our POWR Ratings system. JNJ also has an A grade for Stability and a B grade for Value and Quality. The stock is ranked #5 of 174 stocks in the Medical Pharmaceuticals industry.

Click here to see the other ratings of JNJ for Growth, Sentiment, and Momentum.

AbbVie Inc. (ABBV)

ABBV is engaged in research and development, manufacturing, commercialization, and global sale of medicines and therapies. The North Chicago, Ill.-based concern offers its products in various categories: immunology, oncology, neuroscience, eye care, and womens healthcare. The company markets its products to wholesalers, distributors, government agencies, health care facilities, and independent retailers.

On April 5, ABBVs subsidiary, Allergan, announced positive results from its Phase 3 VIRGO trial evaluating twice-daily administration of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. The successful trials should strengthen the role of VUITY in treating patients with blurry near vision.

On March 17, the company received Health Canadas approval of SKYRIZI to treat adults with active psoriatic arthritis. This approval should accelerate the expansion of ABBVs immunology portfolio in Canada.

On March 15, ABBV and Scripps research collaborated to develop oral antiviral treatments to combat the new variants of Covid-19.

ABBVs net revenues increased 7.4% year-over-year to $14.89 billion in the fourth quarter, ended Dec. 31, 2021. The companys non-GAAP net earnings increased 13.3% from the year-ago value to $5.92 billion, while its operating earnings grew 35.2% year-over-year to $5.07 billion. ABBVs adjusted EPS rose 13.4% from the prior-year quarter to $3.31.

Analysts expect ABBVs EPS and revenue to increase 6.3% and 5.2%, respectively, year-over-year to $3.14 and $13.61 billion in its fiscal first quarter, ended March 31, 2022. The company has an excellent earnings surprise history; it surpassed the consensus EPS estimates in each of the trailing four quarters.

Shares of ABBV have risen 62.7% in price over the past year to close Fridays trading session at $174.96.

ABBV has an overall A rating, which translates to a Strong Buy in our proprietary rating system. Also, it has a B grade for Sentiment and Quality. Also, it is ranked #8 in the Medical Pharmaceuticals industry.

In addition to the POWR Ratings grades I have just highlighted, one can see the ABBV ratings for Growth, Value, Momentum, and Stability here.

Eli Lilly and Company (LLY)

LLY is a drug manufacturing company. Its offerings include Basaglar, Humalog, Humulin, Jardiance, Trajenta, Erbitux, Retevmo, Tyvyt, Emgality, and Reyvow, among various others. The Indianapolis, Ind.-based company distributes its products in the U.S. and eight other countries.

On April 8, LLY delivered its first shipment of diabetes medicine to Ukraine amid the devastating war there. The company will make additional deliveries of medicines, including cancer treatments and COVID-19 treatments, to ease human suffering in that war.

On March 26, the company announced that adults with alopecia areata who took OLUMIANT 4-mg saw at least 90% scalp hair coverage at 52 Weeks in LLYs Pivotal Phase 3 Studies. With such remarkable results, OLUMIANT could become the first medicine ever approved to treat alopecia areata in 2022.

On January 13, the WHO recommended LLYs baricitinib, sold under the brand name Olumiant, in combination with corticosteroids, for patients with severe COVID-19. The drug has been observed to improve the survival rate and reduce the need for ventilation.

In the fourth quarter, ended Dec. 31, 2021, LLYs revenue increased 8% year-over-year to $8 billion. Its non-GAAP net income increased 8% from the year-ago value to $2.27 billion, while its non-GAAP EPS came in at $2.49, representing an 8% year-over-year improvement.

The $2.15 consensus EPS estimate for its fiscal first quarter (ended March 31, 2022) represents a 15.1% improvement year-over-year. The $7.04 billion consensus revenue estimate for the to-be-reported quarter represents a 3.4% increase from the same period last year.

LLY has gained 69% in price over the past year, closing Fridays trading session at $311.69.

The company has an overall A rating, which translates to Strong Buy in our proprietary rating system. It is no surprise that LLY has a B grade for Growth, Stability, Sentiment, and Quality. In the Medical Pharmaceuticals industry, it is ranked #10.

Beyond what we have stated above, we have also given LLY grades for Momentum and Value. Get all the LLY ratings here.

Merck & Co., Inc. (MRK)

MRK is a global provider of health solutions through its prescription medicines, vaccines, biological therapies, and animal health products. The Kenilworth, N.J.-based company operates through two segments: Pharmaceutical; and Animal Health. It offers its products to drug wholesalers and retailers, hospitals, government agencies, and other health care providers.

On April 4, MRK expanded its vaccines manufacturing facility in Elkton to increase the supply of the companys HPV vaccine and enable broad equitable access. With this expansion, MRK should help meet the growing global demand for vaccines.

On March 25, MRK received a positive opinion from EU CHMP for KEYTRUDA for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in five distinct types of cancer. This positive opinion reflects MRKs advancement in the development of cancer treatments.

On March 2, WHO recommended MRKs COVID-19 antiviral pill (molnupiravir), for high-risk patients, such as the immunocompromised, the unvaccinated, older people and those with chronic diseases.

During the fourth quarter, ended Dec. 31, 2021, MRKs net sales increased 24% year-over-year to $13.52 billion. The companys non-GAAP net income increased 84% year-over-year to $4.58 billion, while its non-GAAP EPS grew 84% from the prior-year quarter to $1.80.

Analysts expect MRKs revenues to increase 20.5% year-over-year to $14.56 billion in its fiscal first quarter (ended March 31, 2022). Its EPS is expected to increase 27.8% to $1.79 in the about-to-be-reported quarter. Shares of MRK have gained 20.4% in price over the past year.

MRKs strong fundamentals are reflected in its POWR Ratings. The stock has an overall A rating, which equates to Strong Buy in our proprietary rating system. MRK also has a B grade for Value, Growth, Sentiment, Quality, and Stability. The stock is ranked #2 in the Medical Pharmaceuticals industry.

In addition to the POWR Ratings I have just highlighted, click here to see the MRK ratings for Momentum.

Click here to checkout our Healthcare Sector Report for 2022

PFE shares were trading at $54.01 per share on Monday afternoon, down $1.16 (-2.10%). Year-to-date, PFE has declined -7.84%, versus a -6.71% rise in the benchmark S&P 500 index during the same period.

Shweta's profound interest in financial research and quantitative analysis led her to pursue a career as an investment analyst. She uses her knowledge to help retail investors make educated investment decisions. More...

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PFE: 5 Global Healthcare Stocks to Buy as BofA Warns of a - StockNews.com

REDWOOD CITY, Calif., April 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that it has received feedback via a Type C meeting written response from the U.S. Food and Drug Administration (FDA) related to Adverums planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration (wet AMD). Adverum requested the FDAs feedback to ensure alignment with the regulatory agency ahead of filing the Investigational New Drug (IND) amendment for the Phase 2 trial. The trial is designed to evaluate the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose of ADVM-022, along with new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids.

We are extremely pleased to have feedback from the FDA regarding our clinical development plan for a Phase 2 trial of ADVM-022 in wet AMD. We are looking forward to completing the IND amendment process by mid-2022 and remain on track to initiate our Phase 2 study in the third quarter of 2022, stated Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. ADVM-022 is a single, intravitreal injection gene therapy product that we believe has the potential to provide a durable and safe treatment option that addresses the needs of wet AMD patients, caregivers, retina specialists and health systems.

As an investigator in Adverums OPTIC trial, I am pleased to give my patients the option for a long-lasting, durable treatment for wet AMD, commented David S. Boyer, M.D., physician at Retina-Vitreous Associates Medical Group and member of Adverums Scientific Advisory Board. It is clear that newer long-acting anti-VEGF treatments are needed, especially one that reduces the burden of frequent anti-VEGF injections that many patients currently have to endure. The work that Adverum is doing to advance ADVM-022 as a treatment option is invaluable for patients and the field.

Expected Near-Term ADVM-022 Development Milestones

About Adverum Biotechnologies

Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with neovascular or wet age-related macular degeneration. For more information, please visit http://www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to: statements regarding Adverums plans to initiate a Phase 2 trial of ADVM-022 in wet AMD at the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose; and statements under the caption Expected Near-Term ADVM-022 Development Milestones. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverums novel technology, which makes it difficult to predict the time and cost of product candidate development and regulatory uncertainties; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022.Additional risks and uncertainties facing Adverum are set forth under the caption Risk Factors and elsewhere in Adverums Securities and Exchange Commission (SEC) filings and reports, including Adverums Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Inquiries

Anand ReddiVice President, Head of Corporate Strategy and External Affairs & Engagement Adverum Biotechnologies, Inc.T: 650-649-1358

Or

Investors:Laurence WattsGilmartin GroupT: 619-916-7620E: laurence@gilmartinir.com

Media:Jennifer ArcureCanale CommunicationsT: 917-603-0681E: Jennifer.Arcure@canalecomm.com

Source: Adverum Biotechnologies, Inc.

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Adverum Biotechnologies Proceeds with IND Amendment for ADVM-022 Phase 2 Trial in Wet AMD After Receiving Requested Type C Meeting Feedback from the...

MUNICH, Germany, April 06, 2022 (GLOBE NEWSWIRE) -- ViGeneron GmbH, a next-generation gene therapy company, today announced a target-specific strategic collaboration and option agreement with Regeneron Pharmaceuticals Inc. (Regeneron) to develop and commercialize a gene therapy product based on ViGenerons novel engineered recombinant adeno-associated virus vectors (vgAAVs) to treat an inherited retinal disease (IRD).

Under the terms of the research collaboration, Regeneron and ViGeneron will create and validate vgAAV-based therapeutic candidates for one undisclosed IRD target. ViGeneron receives an upfront payment and research funding. Regeneron has an option for an exclusive license to develop, commercialize and manufacture the vgAAV-based product for the specific target. ViGeneron is eligible to receive an option exercise fee, development and commercial milestone payments, plus royalties on net sales.

ViGenerons vgAAV vector platform is designed to overcome the limitations of existing adeno-associated virus (AAV)-based gene therapies. To date, therapeutically impactful targeting of photoreceptors relies on subretinal vector delivery, which harbors substantial risks of retinal detachment and collateral damage, often without achieving widespread photoreceptor transduction. vgAAV vectors could potentially enable the efficient transduction of target cells via intravitreal injection that allows lateral spreading and minimizes the risk of retinal detachment caused by conventional subretinal injection.

We are delighted to work with Regeneron to potentially provide an intravitreally delivered gene therapy for patients suffering from an inherited eye disease, said Dr. Caroline Man Xu, Co-founder and CEO of ViGeneron. This agreement with Regeneron further validates the potential of our vgAAV platform, which is excellent for us and also delivers a deal value that contributes financing for our platform and proprietary program development activities. Furthermore, it fits into our strategy of developing proprietary programs for selected retinal targets through clinical trials, while maximizing our technology platforms for additional collaboration programs in retinal diseases, CNS and other disease areas with bellwether biopharma. Our aim is to overcome the current limitations of gene therapy and to bring a novel therapeutic approach to patients in need, she added.

About ViGeneron

ViGeneron is dedicated to bringing gene therapy innovations to people in need. The company is advancing its proprietary gene therapy pipeline to treat ophthalmic diseases, while partnering with leading biopharmaceutical players in retinal diseases, CNS, and other disease areas. ViGenerons two novel next-generation gene therapy platforms are geared towards addressing the limitations of existing adeno-associated virus (AAV)-based gene therapies. The first, vgAAV vector platform, enables a superior transduction efficiency of target cells and is designed to overcome biological barriers, thus enabling novel, less invasive routes of administration such as intravitreal injections. The second, REVeRT (REconstitution Via mRNA Trans-splicing) technology platform, allows efficient reconstitution of large genes (>5Kb) in various tissues such as retina, brain, heart, liver, and skeletal muscle. Privately-owned ViGeneron was founded in 2017 by a seasoned team with in-depth experience in AAV vector technology and clinical ophthalmic gene therapy programs and is located in Munich, Germany. For further information, please visit http://www.vigeneron.com

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ViGeneron signs gene therapy strategic collaboration and option agreement with Regeneron for one inherited retinal disease target - BioSpace

Key MessageWhat is already known on this topic

Electrophysiological assessment of eyes with choroidal detachment, a common postoperative change of glaucoma surgery, has not been reported previously.

In the absence of choroidal detachment, rapid functional improvement was observed in the first, second and third order retinal neurons within several days of glaucoma filtration surgery.

Glaucoma, an irreversible disease, is characterised by the loss of retinal ganglion cells (RGCs) and their axons in the retina, with progressive optic-nerve damage and characteristic visual-field defects.1 2 It is the second most common cause of preventable blindness in the world.3 In 2020, 3.6million people over the age of 50 worldwide lost their vision because of glaucoma.4 Visual-field loss typically becomes detectable only after a large number of RGCs are lost.5 RGC damage can be detected by measuring retinal nerve fibre layer (RNFL) thickness using optical coherence tomography (OCT) to capture morphological changes in the early stages of glaucoma.6 The reversibility of some glaucoma-related changes, such as optic disc cupping, lamina cribrosa displacement,7 vessel density and ocular blood flow,8 following intraocular pressure (IOP) reduction in patients with glaucoma has been reported.

The photopic negative response (PhNR), an electroretinographic (ERG) component, is an objective parameter that can be used to estimate RGC function.8 9 It consists of a slow negative wave that follows the positive b-wave of the ERG and is derived from the inner retinal layers, specifically the RGC layer.8 The PhNR amplitude and PhNR/b-wave ratio, defined as PhNR divided by the b-wave, have been reported to worsen in glaucoma.8 9

Investigations of the function of RGCs810 as well as of their microstructure6 11 12 have contributed to the understanding and diagnosis of the pathophysiology of glaucoma. Interestingly, several studies have shown that the PhNR amplitude is significantly lower in glaucomatous eyes than in normal eyes.8 9 Niyadurupola et al10 and Tang et al13 reported that lowering the IOP led to electrophysiological RGC improvement. These studies reported improvements in PhNR in ocular hypertension and glaucoma after several months of IOP-lowering treatments, including eye-drops, laser therapy and surgery. However, there is no information on how early this functional RGC improvement occurs after IOP reduction following glaucoma filtration surgery. Further, there has been no electrophysiological assessment of eyes that developed choroidal detachment (CD), a common postoperative change of glaucoma surgery.14 15

In this study, we evaluated RGC function in the early postoperative period in glaucomatous eyes undergoing filtration surgery using full-field ERG and skin electrodes. Further, we compared these changes in eyes with and without CD.

Patients who underwent glaucoma filtration surgery and preoperative and postoperative ERG recordings at Saitama Medical University Hospital between September 2020 and June 2021 were included. All patients underwent a comprehensive pre-and postoperative ophthalmologic examination, including visual acuity testing, a slit-lamp biomicroscopy and IOP measurement with Goldman applanation tonometry. The most recent preoperative values were used to assess visual acuity. Visual-field tests were performed within 3 months preoperatively. Standard automated perimetry was performed with the Humphrey Field Analyzer (Carl Zeiss Meditec, Jena, Germany) using the 24-2 Swedish Interactive Thresholding Algorithm standard threshold. We measured the axial length (AL) and central corneal thickness (CCT) (Optical Biometer OA-2000, Tomey, Nagoya, Japan) within 3 months preoperatively. All participants underwent cross-sectional imaging to measure the circumpapillary RNFL thickness at each visit using spectral domain OCT (Spectralis OCT, Heidelberg Engineering, Heidelberg, Germany).

Glaucoma was diagnosed based on: (1) glaucomatous changes in the optic nerve head (ONH) observed with fundus photography, such as a vertical cup-to-disc ratio 0.7, rim notch with a rim width 0.1 and/or an RNFL defect (with its edge at the ONH margin greater than that at a major retinal vessel) diverging in an arcuate or wedge shape; (2) glaucomatous visual field defects that met at least one of the Anderson-Patella criteria, that is, a cluster of 3 points in the pattern deviation plot in a single hemifield (superior/inferior) with p<0.05, one of which must have been p<0.01; a glaucoma hemifield test result outside the normal limits, or an abnormal pattern deviation with p<0.05.16 The included patients had manifest glaucoma deemed to require glaucoma surgery owing to high IOP or evidence of progression in the visual field. All glaucoma subtypes and treatment modalities were included. Patients with visual acuity 20/200 were included in the study, whereas those with diabetic retinopathy, and insufficient ERG quality (described in detail below) were excluded. No exclusion criteria were applied for AL, refractive errors, CCT or past ocular surgery history if the patients fulfilled the inclusion criteria. The patients were divided into two groups according to the presence or absence of CD after glaucoma filtration surgery. The presence of CD and CD grading were determined using ultra-widefield fundus photography (California, Nikon, Tokyo, Japan) and grading criteria as previously reported.17

Full-field ERG was recorded using the RETeval system (LKC Technologies, Gaithersburg, MD; Welch Allyn, Skaneateles Falls, New York, USA), a portable ERG device that uses skin electrodes. The pupils were dilated with topical 0.5% tropicamide and 0.5% phenylephrine hydrochloride. The patient adapted to the background light prior to testing. Sensor strips of skin electrodes were carefully placed 2mm below the lower eyelid margin after cleaning the skin with an 80% ethanol-impregnated solution and connected to a lead wire. The stimuli consisted of a red flashing light (intensity of 1.0cd-s/m2, stimulus duration of 4 ms) on a stable blue background light (10cd/m2). Two hundred flashes were delivered at a frequency of 3.4Hz, which has been reported to achieve a good balance between testing time and signal quality.18 Signal acquisition was performed at a sampling frequency of 2kHz.

The recording time was 220ms, including 100ms of prestimulus recordings. The implicit times and amplitudes of the ERGs were automatically analysed using the software integrated into the RETeval system. The a-wave amplitude was measured from the average pre-stimulus mean baseline to the a-wave trough. The b-wave amplitude was measured from the a-wave trough to the b-wave peak; the a-wave and b-wave peak times were measured from the time of the flash to the peak of the wave.19 The PhNR was selected as the most negative trough appearing behind the b-wave according to the standard of the International Society for Clinical Electrophysiology of Vision.8 Its amplitude can be measured in various ways; in this study, it was measured from the b-wave peak to the PhNR trough (PT) (as shown in online supplemental figure 1). We also analysed the PT/b-wave amplitude ratio; the PT amplitude and PT/b-wave amplitude ratio have been reported to be highly reproducible.20 These indices were analysed using the well-recorded ERG waves that had a stable recorded baseline. When the last point of the recorded waveform deviated from the baseline level before recording by 3SD or more of the noise amplitude, it was judged that the baseline of the recorded waveform was unstable and defined as an ERG wave with insufficient quality. The fluctuation range of the baseline before recording was regarded as the noise amplitude. It was measured in 10 randomly selected eyes according to the manufacturers instructions and was measured to be 1.30.9 V. Therefore, the reference value was defined as 5.1 V. Preoperative ERGs were recorded the day before surgery, and postoperative ERGs were measured within 2 weeks.

The significance of the differences within the groups was compared using the paired t-test and that between the groups was compared using Students t-test. Pearson 2 and Fishers exact test were used for categorical variables. We analysed the relationship between the change in PhNR amplitude and various structural and functional factors such as age, AL, CCT, preoperative and postoperative IOP, preoperative mean deviation (MD) values by HFA 24-2, past surgical history, presence or absence of postoperative CD, change in visual acuity and self-reported systemic diseases. Decimal visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. Variables with p<0.10 in the univariate analysis were used for multivariate analysis. In addition, to confirm the intersession reproducibility, we randomly selected 15 patients and measured the preoperative and postoperative PhNR amplitudes and implicit times in the non-operated eye and calculated the coefficient of variation (CV) values. Statistical significance was set at p<0.05 based on a threshold two tailed. Distributed variables are reported as mean (95%CI), except for age, which is reported as the median (quartile). We used the JMP Pro V.16 software (SAS Institute) for the analyses.

Figure 1 shows a flow diagram of the study patients. Seventy-four patients were initially enrolled in the study. Seventeen patients were excluded because of poor visual acuity (five eyes), diabetic retinopathy (five eyes) and insufficient ERG quality (seven eyes; three eyes had insufficient quality preoperatively, two eyes had insufficient quality postoperatively and two eyes met the criteria for insufficient quality in both preoperative and postoperative measurements). Among the 4 eyes that showed insufficient ERG quality and IOP of less than 10mm Hg, 2 eyes showed CD (2 eyes out of 11 eyes: 18.2%), and the other 2 eyes had no CD (2 eyes out of 46 eyes: 4.3%), and there was no significant difference. Thus, the data of 57 patients were included in the analysis, including those of 46 patients without CD and 11 with CD. Table 1 summarises the characteristics of the two groups. There were no significant between-group differences in age, gender distribution, preoperative best-corrected visual acuity, preoperative mean deviation, preoperative IOP, distribution of glaucoma subtypes and whether cataract surgery was concomitantly performed. As expected, the postoperative IOP value was significantly lower in the CD group (6.4 (4.6 to 8.1)mm Hg, mean (95%CI)) than in the non-CD group (9.7 (8.6 to 10.7)) mm Hg (p=0.003). Other factors such as age, gender distribution, preoperative IOP, preoperative MD value, CCT, AL, self-reported systemic diseases and past ocular surgery history were not significantly different between the groups.

Patientcharacteristics

Flow diagram of study patients. CD, choroidal detachment; ERG, electroretinography.

Figure 2 shows three eyes of the representative cases from the non-CD group. Compared with before glaucoma surgery, IOP decreased and PhNR amplitude improved after surgery in all three cases. Figure 3 shows two eyes of representative cases from the CD group. In both cases, transient CD (grade 2) occurred after glaucoma surgery, and PhNR amplitude deteriorated compared with before surgery. CD recovered spontaneously and disappeared after 1month and the PhNR amplitude also improved.

Representative cases from the non-CD group of preoperative (left column) and postoperative (middle column) electroretinography results and widefield fundus photography (right column). Case 1 was an 84-year-old man. His IOP was 23mm Hg preoperatively. The day after the surgery, his IOP decreased to 11mm Hg and his PhNR amplitude improved. Case 2 was a 64-year-old man. His IOP was 28 mm Hg preoperatively, and on the seventh day of surgery, his IOP decreased to 7mm Hg and his PhNR amplitude improved slightly. Case 3 was a 72-year-old man. His IOP was 20mm Hg preoperatively, and on the third day of surgery, his IOP decreased to 9mm Hg and his PhNR amplitude improved slightly. CD, choroidal detachment; IOP, intraocular pressure; PhNR, photopic negative response.

Representative cases of the CD group preoperatively (left column), early postoperatively with CD (middle column), and postoperatively after spontaneous recovery of CD (right column). Case 4 was a 74-year-old woman. Six days after surgery, the IOP decreased to 7mm Hg, and a grade 2 CD was confirmed by wide-angle fundus photography. PhNR amplitude had also worsened. One month later, the CD recovered spontaneously and the PhNR amplitude improved. Case 5 was a 73-year-old woman. The preoperative IOP was 28mm Hg. On postoperative day 4, the IOP was 10mm Hg, but wide-angle fundus photography showed grade 2 CD, and the amplitude of the PhNR also deteriorated. One month later, the CD recovered spontaneously and the amplitude of the PhNR improved. CD, choroidal detachment; IOP, intraocular pressure; PhNR, photopic negative response.

The changes in ERG parameters preoperatively and postoperatively for each group are summarised in table 2. The scatter plots in figure 4 show the changes in the PhNR implicit time and amplitude and the PhNR/b-wave amplitude ratio.

Scatter plots showing the change in PhNR implicit time and amplitude and the PhNR/b-wave amplitude ratio. Scatter plots of each PhNR parameter pre -and postoperatively. The x-axis shows the preoperative values, and the y-axis shows the postoperative values. In the plot, the circle indicates the non-CD group and the cross indicates the CD group. (A) PhNR amplitude. (B) PhNR/b-wave amplitude ratio. (C) PhNR implicit time. CD, choroidal detachment; PhNR, photopic negative response.

Comparison of full-field ERG parameters before and after the operation

In the non-CD group, the PhNR amplitude, PhNR/b-wave amplitude ratio and PhNR implicit time significantly improved after surgery. The PhNR amplitude changed from mean (95%CI) 17.3 (15.6 to 19.1) V to 18.7 (16.7 to 20.6) V (p=0.008). The PhNR/b-wave amplitude ratio changed from 0.86 (0.84 to 0.89) to 0.90 (0.87 to 0.93; p=0.002). The PhNR implicit time changed from 75.3 (72.6 to 78.0) to 72.3 (70.4 to 74.3) ms (p=0.039). In addition, the a-wave and b-wave implicit times significantly improved after surgery. The a-wave implicit time changed from 14.8 (14.4 to 15.2) ms to 14.3 (14.0 to 14.7) ms (p=0.027). The b-wave implicit time changed from 32.2 (31.5 to 32.9) ms to 31.4 (30.9 to 32.0) ms (p=0.004).

In the CD group, the PhNR amplitude significantly deteriorated after surgery. The PhNR amplitude changed from 17.0 (12.4 to 21.5) V to 11.4 (7.7 to 15.0) V (p=0.002). In addition, the a-wave and b-wave amplitudes significantly deteriorated after surgery. The a-wave amplitude time changed from 4.9 (6.0 to 3.8) V to 3.1 (4.2 to 2.0) V (p=0.001). The b-wave amplitude changed from 19.1 (14.5 to 23.8) V to 13.3 (9.3 to 17.3) V (p=0.001). The PhNR/b-wave amplitude ratio, PhNR implicit time, a-wave amplitude, and b-wave amplitude did not change significantly.

Figure 5 shows the distribution of change in the PhNR amplitude in the CD group and the non-CD group. The postoperative change in PhNR amplitude was significantly lower in the CD group than in the non-CD group (p<0.001). Table 3 shows the results from the univariate and multivariate models investigating the relationship between the change in the PhNR amplitude and related factors. Postoperative IOP (p=0.031) and postoperative CD (p<0.001) were significantly associated with change in the PhNR amplitude in the univariate models. We separately examined the presence of postoperative CD and postoperative CD gradings with two different multivariable models. In the multivariate analysis, the presence of postoperative CD, CD grading 1 (p=0.048) and 3 (p=0.004) were significantly correlated with change in the PhNR amplitude.

Association between change in PhNR amplitude and ocular variables: univariate and multivariable analysis

Distribution of change in the PhNR amplitude in the CD group and the non-CD group. CD, choroidal detachment; PhNR, photopic negative response.

The CV values were 12.4% (95% CI 7.5% to 17.4%) for the PhNR amplitude, 2.4% (95% CI 1.1% to 3.7%) for PhNR/b-wave amplitude ratio and 6.0% (95% CI2.6% to 9.5%) for PhNR implicit time.

In this study, we demonstrated the rapid improvement in RGC function within several days after glaucoma filtration surgery by measuring PhNR using skin electrodes in the same eye preoperatively and postoperatively. The PhNR amplitude worsened after glaucoma surgery in patients with CD because of overfiltration.

Interestingly, the a-wave, b-wave and PhNR improved after glaucoma filtration surgery. This suggests the possibility that the reduction in IOP may be related to changes in blood flow in deeper layers. Deep macular microvasculature alteration in glaucomatous eyes has recently been reported.11 21 Further studies on whether this deep circulatory impairment can be improved by lowering IOP would provide an answer. Using OCTA, we recently reported microcirculatory disturbances in the macula before and after glaucoma surgery.22 23 The foveal avascular zone area was significantly reduced at 3 months after surgery. We concluded that capillary circulation may improve to a level detectable with OCTA. IOP, microcirculation and physiological improvements in function are considered closely related and act together quite early in the postoperative period.

RETeval is a relatively new ERG recording system that uses skin electrodes and is less invasive.24 RETeval PhNR is simple, reproducible and carries a low risk of infection when observing acute functional changes in the dense perioperative period.24 25 Using this method, it was possible to observe retinal function 2hours after vitreous injection26 and several days after vitrectomy.27 In this study, we showed that skin electrode ERG can be used to evaluate retinal function in the early postoperative period, even in eyes after filtration surgery that cannot tolerate contact lenses and DTL electrodes.

Another notable finding of this study is the significant association between the presence of CD soon after postoperative glaucoma filtration surgery and changes in retinal function observed using skin electrode ERG. In some situations, mild CD is difficult to detect. Objective diagnosis of the presence or absence of CD in the early postoperative period is practical and could help decide on further management.28 This study showed that the behaviour of the ERG components recorded in the early postoperative period strongly correlated with the presence of CD. The a-wave, b-wave and PhNR waves deteriorated in the CD group. First, choroidal function may play a role. Miyake et al15 analysed the electrooculogram of eyes with rhegmatogenous retinal detachment (RRD) and found that the preoperative values were significantly lower in eyes with CD than in those without. Choroidal dysfunction may affect outer retinal layer function, leading to changes in the a-wave and subsequently in the b-wave and PhNR. Second, another explanation is that the inner protrusion of the retinal surface caused by CD may have reduced the response of the ERG because of unequal stimulus light exposure. The fact that the amplitude deteriorated but the implicit time was relatively maintained is consistent with the latter explanation. Third, the effect of IOP on ERG changes should be considered. Miyake et al29 used ERG to monitor retinal function during scleral buckling surgery in eyes with RRD. They observed a marked decrease in retinal function immediately after subretinal fluid drainage, but it improved with increased IOP caused by buckling. Therefore, the authors stated that the functional reduction was attributed to the effect of low IOP. In this study, eyes with CD also had a lower IOP than those without. However, rapid IOP reduction does not always cause reduction in the ERG response, as shown by studies of electrophysiological monitoring during intravitreal injection.30 31 Further studies are required to validate this mechanism.

Recently, Shin et al reported on CD grading using wide-angle photographs.17 The widespread use of wide-angle fundus photography has enabled objective interpretation of the degree of CD. In this study, we showed a significant association between CD grading and PhNR amplitude change. They showed the risk of CD was associated with pseudoexfoliation glaucoma, older age, and previous cataract surgery. Though there was no statistically significant difference between the two groups in this study, the results were consistent with the past reports by Shin as the CD group was older, had more cases of pseudoexfoliation glaucoma, systemic hypertension and diabetes, and previous cataract surgery.

The limitations of this study include its retrospective design, small sample size and lack of long-term postoperative data. It is possible that the deterioration of the PhNR amplitude may improve with the improvement of CD, and it is unclear how long the improvement of the PhNR amplitude will persist. Further studies with longer follow-up periods will clarify these associations. Second, it can be argued that the improved PhNR after surgery could be a result of improved media factors rather than the recovery of retinal function. Preoperative corneal oedema and combined cataract surgery may influence ERG quantitative measurements. In this study, the proportion of patients with a history past ocular surgery history was similar in the groups. Simultaneous cataract surgery was performed in 22 out of 46 eyes (47.8%) in the CD group and 3 out of 11 eyes (27.2%) in the non-CD group, and cataract surgery may have affected the postoperative changes in ERG. Tanikawa et al32 conducted a detailed study on the effects of cataract surgery on ERG. They reported a significant increase in the a- and b-wave amplitudes, but not in PhNR, after cataract surgery. In addition, after excluding eyes with preoperative IOP higher than 30mm Hg (five eyes) from the analysis, the results were similar (online supplemental table 1). Thus, the impact of media factors on PhNR, if any, may be considered inconsequential for the results of this study. Third, the influence of the hypotonic state on the ERG quality may be a cause of concern for selection bias. The comparisons of the ERG parameters between CD and non-CD groups should be interpreted with caution; however, the incidence of the excluded eyes due to insufficient ERG similar in the groups (data not shown).

In conclusion, even in the early postoperative period within several days, the PhNR amplitude increased with IOP lowering following filtration surgery, and showed rapid functional recovery. However, the appearance of CD identified by wide-field fundus photography suggests that CD may arrest functional recovery, at least temporarily. The present results enhance understanding of the structural and functional recovery after glaucoma surgery and the role of postoperative CD.

Data are available on reasonable request. The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.

Consent obtained directly from patient(s)

The present study was part of a prospective longitudinal study approved by the Ethics Committee of the Saitama Medical University (No. 15138) and conducted in accordance with the tenets of the Declaration of Helsinki. The detailed design of this longitudinal study has been described previously. The Ethics Committee of Saitama Medical University approved the present study and waived the requirement of additional informed consent due to the retrospective nature of the study (No. byou2021-074).

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Early changes in photopic negative response in eyes with glaucoma with and without choroidal detachment after filtration surgery - British Journal of...

Newswise The road from discovering a potential drug to getting the therapy into the hands of patients is a long and uncertain one.

Konstantin Petrukhin, Ph.D., ought to know.

In 2011, after years working at the bench, the professor of ophthalmic sciences at Columbia University Medical Center, discovered a promising drug candidate for treating the most common form of age-related macular degeneration (AMD). This blinding eye disease affects millions of Americans, and atrophic or dry AMD accounts for 90% of cases. There is currently no treatment for dry AMD.

The therapy, known as LBS-008 (formerly BPN-14967), appears to be promising for other retinal degenerative diseases such as Stargardt disease, a rare, inherited condition that causes vision loss during childhood and young adulthood.

The cherry on top: Petrukhin identified a biomarker that could easily be measured in a persons blood to confirm the drugs level of activity and fine tune dosage. LBS-008 is a tablet taken by mouth, sparing patients the need for an injection into the eye, which is a common mode of delivery for therapies that must reach the light-sensitive retinal tissue at the back of the eye.

Despite all that LBS-008 had in its favor, Petrukhin had only cleared the first hurdle. The next would involve finding a biopharmaceutical firm willing to take the risk of shepherding the new drug to the market.

For every drug that successfully makes it into the hands of patients, nine fail somewhere along the clinical trial pipeline.[1] On average, it can take up to 15 years and $1 billion to bring a new drug to market, accounting for the failed drug candidates.[2]

Much of that time and money is spent meeting rigorous regulatory requirements established by the U.S. Food and Drug Administration. These requirements are in place to safeguard the health of patients. Before a new drug is FDA-approved, it must demonstrate safety and efficacy in a lengthy three-phase clinical trial process.

And before clinical trials can even begin testing in humans, the FDA requires preliminary support for the safety, efficacy, and quality of the investigational therapy. That means information about the agents performance in preclinical animal studies assessing efficacy and toxicology, detailed clinical protocols and manufacturing plans.

It takes a team of experts with a wide range of expertise to advance a candidate drug to clinical trials, Petrukhin said. Basic science researchers in academia typically do not have access to all the necessary skills to get their novel therapeutics strategies to the point where a biopharmaceutical firm would be interested in taking on a promising drug through the clinical trials process.

For that expertise, Petrukhin turned to the National Institutes of Health Blueprint Neurotherapeutics Network for Small Molecules. Launched in 2011, the network provides a framework for researchers like Petrukhin, who have a promising candidate treatment for an unmet medical need, to attract pharmaceutical company interest.

How the NIH Blueprint program works

The network, which is funded and administered by a consortium of NIH institutes, including the National Eye Institute, provides principal investigators like Petrukhin access to a full range of industry-style drug development services and expertise. Each project forms a lead development team composed of the principal investigator, as well as NIH staff and industry consultants hired by NIH. The network provides principal investigators with access to Contract Research Organizations (CROs) and a team providing cross-functional expertise from assay development and pharmacology to medicinal chemistry, pharmacokinetics, toxicology, formulation development, and Phase I clinical testing.

If a researchers project requires a consultant that has a specific type of expertise such as regulatory affairs or drug manufacturing, we have a diverse group of consultants with years of experience in the pharmaceutical industry who provide guidance in areas such as the FDA regulatory process and the steps involved in developing a useful drug product, free of charge. Essentially, researchers have access to a virtual pharma company tailored to their project through their lead development team and NIH contracts, said Mary Ann Pelleymounter, Ph.D., a scientific project manager for the Blueprint Neurotherapeutics Network for Small Molecules.

Academic and small business researchers are provided with the tools and resources to navigate the drug discovery process in an efficient way that is intended to optimize the probability of success, added Pelleymounter who managed Petrukhins lead development team.

The Blueprint Neurotherapeutics Network was NIHs response to the fact that most nervous system and neurodegenerative disorders lack effective treatment, and most of the potential neurotherapeutic agents identified from basic research do not make it to human testing.

As tough as it is to bring new drugs to market in general, neurotherapeutics have an even steeper hill to climb. They have a long track record of failure and a limited pool of validated treatment targets and strategies on which to build, which resulted in pharma companies exiting the neuroscience research area, said Charles Cywin, Ph.D., program director for the Blueprint Neurotherapeutics Network.

Inherited neurological disorders also tend to affect relatively small populations, which reduces the potential upside for a company taking on the risk.

Finally, neurotherapeutic clinical trials often are expensive because many of the disorders, such as AMD, are neurodegenerative, progressing over years, necessitating lengthy and costly trials to determine if a treatment is working.

The Blueprint Network aims to de-risk candidate therapeutic agents to the point that these projects are attractive investments for pharma, biotech and venture firms, and allows these exciting basic research findings to become potential new drugs to reach patients efficiently, Pelleymounter said.

In 2011, Petrukhins project was selected by the NIH Blueprint Program and received sufficient funding and contract resources to support development of LBS-008 from early discovery through Phase Ia clinical testing.

In 2017, the San Diego-based biopharmaceutical company Belite Bio Inc. (formerly Lin Bioscience) selected LBS-008 for its portfolio to support clinical testing of this candidate therapeutic. By June 2021, the company had launched a late-stage Phase 3 clinical trial of LBS-008 in patients with Stargardt disease. As a potential treatment for a rare disease, testing the drug first in Stargardt enabled LBS-008 to be granted an orphan-drug designation, which qualifies Belite Bio for tax credits and an extended period of market exclusivity after approval. If LBS-008 is approved, it will accelerate the clinical trial process for an atrophic AMD indication.

Under the agreement, Belite Bio holds exclusive global licensing rights. Along with other co-inventors, Petrukhin maintains relevant patents. Columbia University holds the rights to the intellectual property portfolio. If approved, the drug will be marketed as Tinlarebant.

How the LBS-008 therapy works

Petrukhin designed his therapeutic strategy based on a long-observed phenomenon in patients with atrophic AMD and Stargardt disease. Their retinas tend to have an accumulation of lipofuscin, a yellow-brown lipid-based substance associated with aging. Granules of lipofuscin accumulate in a retinal layer called the retinal pigment epithelium (RPE), which supports the health of light-sensing photoreceptors. In both atrophic AMD and Stargardt disease, vision loss occurs when photoreceptors die, but their death happens secondary to the loss of RPE cells. Petrukhin and others hypothesized that reducing harm from lipofuscin might prolong RPE and photoreceptor survival.

The best studied toxic component of lipofuscin is the bisretinoid A2E, a by-product of the normal visual cycle, the vital biochemical pathway that regenerates visual pigment, and is important for converting light (photons) into electrical signals sent from the retina to the brain.

A2E production depends on the influx of retinol from blood to the RPE. Whats more, retinol uptake from blood circulation is dependent on the function of retinol-binding protein 4 (RBP4).

Petrukhin asked whether reducing the retinoid load of the visual cycle with an RBP4 antagonist might reduce A2E production just enough to stave off AMD and Stargardt disease, without interfering too much with the necessary biochemical pathway required for vision.

In his search for a way to inhibit RBP4, Petrukhin came across some papers describing an RBP4 antagonist compound that had initially been developed by the pharmaceutical company Amgen as a potential treatment for diabetes. Long since shelved for diabetes, Petrukhin began tests to see if the RBP4 antagonist might lead to a therapeutic reduction of lipofuscin bisretinoids. That compound (called A1120) was a starting point for optimization that eventually yielded LBS-008, a drug candidate that is currently in clinical development.

In unpublished mouse studies, LBS-008 reduced levels of RBP4 in the blood by 93% after 12 weeks, and A2E levels were reduced by 80% in treated mice compared to controls.

Furthermore, in mouse models of Stargardt disease, compared with controls, LBS-008-treated animals had significantly greater preservation in the thickness of their outer nuclear layer, a cell layer that consists of photoreceptors that becomes thinner with disease-related damage.

Petrukhin notes that several other companies have since adopted similar RBP4 antagonist strategies for reducing lipofuscin bisretinoids. So, the field has become very crowded, which tells we made the right choice, he said.

Today, Petrukhins lab is continuing to explore optimal strategies for developing the next generation of RBP4 antagonists, which are not only potential therapies for eye diseases, but may also be used as a treatment for metabolic diseases such as non-alcoholic fatty liver disease and type 2 diabetes.

Building on the success of the initial Blueprint Neurotherapeutics Network for Small Molecules (that is, therapies like Petrukhins that enter cells and work at a molecular level), the program recently expanded to support lead optimization for biologic therapies, which are treatments derived from substances made from living organisms.

This is an exciting new opportunity for vision scientists working on some of the most promising biologic-based therapies, such as gene therapies, or cell-replacement therapies, said Thomas Greenwell, Ph.D., a program director for the NEI and for Blueprint. To learn more about the Blueprint Neurotherapeutics Network: Biologic-based Drug Discovery and Development for Disorders of the Nervous System, visit https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics

Clinical trials testing LBS-008, also known as BPN-14967 are NCT05244304, NCT04005807, NCT05266014, NCT03735810.

Links

Blueprint Neurotherapeutics Network (BPN) for Small Molecules

Age-related macular degeneration

Stargardt disease

Safety and Tolerability Study ofLBS-008in Healthy Adult Subjects After Single and Multiple Doses on Clinical Trials.gov

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Advancing a Treatment for a Common Eye Disease That Lacks One - Newswise

Bala Ambati, an ophthalmologist and research professor in the Phil and Penny Knight Campus for Accelerating Scientific Impact, has seen a lot over the course of his 25-year career.

A leading eye surgeon, vision science pioneer and medical missionary, he has helped repair or restore vision to countless patients around the world, and researchers in his lab in the Knight Campus continue to develop treatments to prevent or reverse blindness, provide clearer vision and reduce the need for corneal transplants.

Ambati will focus on the cornea, the window to the eye, and provide an overview of the history of vision science, as the featured speaker at Science Knight Out, a community science talk sponsored by the Phil and Penny Knight Campus for Accelerating Scientific Impact.

RSVP online to the virtual event, slated for 4 p.m. Thursday, April 14.

Ambatis talk, Eye on the Cutting Edge: Healing the Window on the World, will highlight research from his lab, including a new gene therapy that could eventually provide an alternative treatment for Fuchs endothelial corneal dystrophy, a genetic eye disease affecting roughly one in 2,000 people globally. Currently, the only treatment is corneal transplant, a major surgery with associated risks and potential complications.

An ophthalmologist at Pacific Clear Vision Institute in Eugene, Ambati will also explore some of the breakthroughs in vision science over the past 20 years. In addition to performing thousands of cataract surgeries, LASIK and other vision correction procedures, he has alsoserved as a volunteer eye surgeon in Ghana, Zambia, India, Panama, Indonesia, the Philippines and Malaysia.

I love having the ability to take care of my patients and to help them see, Ambati said. I also love the ability to work with a fantastic group of people here at the Knight Campus and in my lab to come up with the next generation of cures and treatments to help patients around the world for years to come.

A visionary researcher and highly regarded clinician with an entrepreneurial drive, Ambati co-founded iVeena, a startup focused on developing an eyedrop for corneal strengthening and an implant for drop-free cataract surgery. Prior to joining the Knight Campus in July 2020, he completed his residency at Harvard University and a fellowship at Duke University.

Hehas been in practice 17 years as a cataract, cornea and refractive surgeon. He was director of cornea at Medical College of Georgia for five years and most recently was professor and director of cornea research at the University of Utah. Having graduated at 17 from Mount Sinai School of Medicine as the worlds youngest doctor, he was cited in 2015 as the No. 1 eye surgeon in a top 40 under 40 global competition and made the Top 100 Power List of Ophthalmology by The Ophthalmologist magazine.

Ambati has been recognized for his teaching excellence with a University of Utah Resident Research Mentor Award and the Gold Humanism Award. He servedas an instructor at the Harvard Cataract Course.

Ambatis talk will mark the sixth installment of Science Knight Out lecture series, which dates to 2017.

Past events were headlined by Leslie Leve, associate director of the UOs Prevention Science Institute; Robert E. Guldberg, vice president and Robert and Leona DeArmond Executive Director of the Knight Campus; Patrick Phillips, UO provost and senior vice president; Laura Lee McIntyre, director of the Prevention Science Institute and professor in the College of Education; and David McCormick, director of the Institute of Neuroscience.

Recordings of all past lectures are available on the Science Knight Out web page.

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Knight Campus talk to focus on the cornea and vision science - AroundtheO

A new database study found that patients with diabetes and rosacea were at a significantly higher risk of diabetic macular edema, glaucoma with medical treatment, dry eye disease, and cataract surgery compared to patients without rosacea.

In previous research, rosacea has been associated with a variety of systemic comorbidities including gastrointestinal, cardiovascular, neurologic, psychiatric, and metabolic diseases.

Diabetes has also been associated with several ocular diseases, with previous research suggesting a systemic inflammatory component. Though the role of inflammation in diabetic eye diseases has been studied, no research has been conducted regarfing ocular complications in patient with diabetes due to rosacea.

Investigators led by Chau Yee Ng, MD, Chang Gung Memorial Hospital, Taiwan, detailed the association between rosacea and eye diseases in patients with diabetes via a retrospective cohort nationwide study.

Ng and colleagues included all patients diagnosed as having diabetes mellitus who received hypoglycemic agents between January 1, 1997, and December 31, 2013.

A total of 2,099,303 patients were identified, 5459 of whom had been diagnosed with rosacea. After applying exclusions criteria, 4096 diabetic patients with rosacea were matched 1:4 with 16,384 diabetic patients without rosacea.

From there, investigators compared the risk of time-to-event outcome between rosaces and non-rosacea groups in the propensity score matching cohort using the Fine and Gray sub-distribution hazard model.

Following a mean follow-up period of 5 years, investigators observed that patients with diabetes and rosacea had significantly higher risks of diabetic macular edema (sub-distribution hazard ratio [SHR]: 1.31, 95% CI: 1.05-1.63), glaucoma with medical treatment (SHR: 1.11, 1.01-1.21), dry eye disease (SHR: 1.55, 1.38-1.75), and cataract surgery (SHR: 1.13, 1.02- 1.25) compared with patients without rosacea.

Additionally, the team observed a significant association between psoriasis, irritable bowel syndrome, anxiety, and depression in patients with diabetes and rosacea compared to patients without rosacea.

In this retrospective cohort nationwide database study, diabetic patients with rosacea had significantly higher risks of diabetic macular edema, glaucoma with medical treatment, dry eye disease, and cataract surgery compared with patients without rosacea, the team wrote. This is the first study demonstrating the association.

The findings were presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston.

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Diabetic Patients with Rosacea at Increased Risk of Ocular Disease - MD Magazine

The retinal disease burden in India is on the rise. While 35% of the Indian population needs some form of vision correction only 25% of those have had their vision corrected. This is mainly since retinal diseases can go unnoticed for a long time, as some have no symptoms at first. A comprehensive eye exam by a retina specialist or ophthalmologist is necessary to find these diseases in the early stages, when treatment to prevent vision loss is most effective.

Eye examinations includes test visual acuity, depth perception, eye alignment, eye movements and eye pressure measurement. Eye drops are used to make your pupils larger so your eye doctor can examine the retina and also check for signs of health problems. An ophthalmologist may be the first to detect conditions such as high blood pressure or diabetes, sometimes before your primary care doctor does.

Eye Exams: How Often?

Eye checkups are advocated, as a routine, for all children before the age of 5 years and there after once a decade till the age of 40 years. During the presbyopic years it is advisable to have checkup every 2-3 years. Children with glasses need checkup after 6 months till end of schooling. People with specific eye ailments like squint, Glaucoma, Uveitis, retinopathies require closer follow-ups as advised by the ophthalmologist. People with diabetes should have a dilated eye exam every year.

Better managing eye health

The most important step in an eye disease treatment is its early diagnosis. The patient must adhere to the four-point vision loss prevention program that includes regular eye examination, good control on your diet, a healthy lifestyle, and keeping an eye on vision problems.

In a similar manner, diabetic patients are required to monitor their blood sugar levels. Keeping a regular check on their diet, post-lunch sugar levels, and following doctors advice can help maintain the ideal HbA1c levels. Antidiabetic medicines coupled with lifestyle modifications such as, a healthy diet plan, exercising, and smoking cessation is the path towards efficiently managing diabetes. It is key to manage diabetes to halt the eye diseases that come with the territory.

A diabetic patient is simultaneously required to be a key observer of their vision aberrations. If vision suddenly changes or becomes blurry, spotty, or hazy, contacting an ophthalmologist immediately will prove beneficial. Ensuring an early detection of Diabetic Retinopathy & Diabetic Macular Edema, and an early diagnosis allows effective treatment and prevents complications like irreversible vision damage. A regular eye check-up is crucial for a diabetic to avoid any delay of treatment and hence vision loss.

Vision care beyond treatment

The technological and medical advancements today have brought in a number of treatment options that can be availed, such as focal laser treatment, anti-VEGF injections, surgery etc. Whats important is to understand and adhere to regular check-ups. Visiting the doctor every 6 months allows the patient and doctor to catch the condition in its early stages and find an accurate treatment for it. Ensuring a regular contact with the eye doctor to find correct medication, treatment options, treatment process, and care should be a priority for the patient. Treatment helps immensely, but following up on scheduled appointments, ensuring that your eye health doesnt derail again is equally important.

The COVID pandemic had a devastating effect of the health of the people worldwide. The repeated long periods of lockdowns, reduced access to healthcare facility and restricted transport resulted in majority of patients with co-morbidities not seeking medical aid at an appropriate time. While some were lucky to avoid lasting side-effects to delayed treatment, many had to pay a heavy price for the delay.

Views expressed above are the author's own.

END OF ARTICLE

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Regular eye examinations, are key to early stage disease detection: Dr Girish Rao - Times of India

While walking in a grassy or wooded area, there is an increasingly prevalent infectious disease that can be contracted from the bite of an unseen tick.

Annually, half a million people in the United States develop Lyme disease. Over the last two decades, there has been a sharp rise in both the number of cases and the geographic distribution of the malady.

The disorders clinical course is variable; the majority of the afflicted have mild symptoms and usually recover after taking antibiotics. In those that are untreated or have a therapeutic failure, complications involving multiple organs systems may ensue; it can last from months to years. The condition is rarely fatal.

Lyme disease is caused by the spirochete bacterium borrelia burgdorferi that is transmitted to humans through the bite of an infected black-legged tick, commonly known as a deer tick.

While the ailment is primarily observed on the East Coast, it has been reported in all states except Hawaii. The disorder can occur in any season but is most common from May to August.

Only a minority of tick bites lead to an infection. The longer the insect remains attached to the skin, the higher the threat of getting the disorder. If affixed less than 36-48 hours, the risk of contracting the illness is greatly reduced.

Once the bacteria enter the blood stream, the pathogens spread throughout the body. Feeling ill stems from the immune systems response to the microorganisms in various tissues and organs.

Untreated individuals go through several stages with different clinical characteristics in each phase that frequently overlap.

During the initial manifestations, flue-like symptoms of fever, chills, body pain, headaches, neck stiffness and swollen lymph nodes occur. These indices are associated with a distinctive rash (erythema migrans) that develops 3-30 days after an infected tick bite.

This skin eruption which appears as a bulls eye is annular, reddish, with or without a central clearing and neither itchy nor painful. It expands slowly and can spread up to 12 inches. Up to 30% of those infected may not form a rash, or its presence was overlooked.

If you notice a tick on you but dont develop the telltale bulls-eye-shaped rash, dont assume that youre in the clear; its still possible to develop Lyme disease. Be on the lookout for symptoms including fever, chills and aches and pains, and if you notice any, go to the doctor immediately.

In those with untreated disease and a small subset of victims with treatment failure, serious more broadly distributed findings can appear. These include facial palsy, meningitis, cardiac abnormalities, severe joint pain, arthritis and eye inflammation.

An early diagnosis can be a difficult task.

An article in Frontiers of Medicine notes that outside of the diseases nascent ruddy rash, proof of the disorder relies on non-specific clinical signs that in the initial stages may not be supported by laboratory data.

A delay in confirmation of the condition occurs in upwards of 40% of those ultimately diagnosed. Frequently these individuals will have advanced clinical findings as a consequence of the stalled recognition of the malady.

One explanation for the lag in diagnosis is that many who have been exposed to ticks often ignore non-specific symptoms particularly when there is an absence of a rash. They do not seek timely medical advice.

For those with classic clinical findings, doctors can make the diagnosis with near certainty when an expanding bulls eye red rash is present. For the less-apparent cases, a combination of a history of tick exposure, physical exam and blood tests to detect antibodies can usually confirm the diagnosis.

Humans have been inflicted with the tick-borne bacteria since ancient times.

The oldest known case was documented in a 5,300-year-old iceman found in a glacier in the Italian alps. Closer to the present, in Colonial America there were many early settlers who suffered from Lyme-like symptoms. An abundance of ticks dwelled in the forests in the northeastern colonies. The diseases modern moniker emanated from the town of Lyme, Connecticut, where the disorder was documented in the 1970s.

Unlike in the 17th and 18th centuries, preventive measures are known today. These include using insect repellants, wearing light-colored clothing and checking for and safely removing ticks after a walk. When these precautionary measures fail, and one is faced with the diagnosis of LD, effective treatment is available for most cases.

The earlier the therapy begins, the better the prognosis.

Antibiotics are the definitive medications for Lyme disease. When more advanced symptoms are present, the drug is continued for a longer period. For those with post-treatment reoccurrence, there is less of a consensus as to the treatment regimen for this poorly understood subsegment of the disorder.

While there are ongoing investigations for new therapeutic modalities, a safe and efficacious vaccine has become a priority.

Historically, a Lyme disease vaccine for adults was approved by the FDA in the late 1990s, but it was withdrawn in 2002 by the manufacture because of the limited response in the marketplace. Currently, a vaccine has renewed research attention; there are some promising products in the preclinical phase.

Lyme disease is not only a human disorder its common in mans best friend.

Veterinarians in endemic areas are familiar with the afflictions symptoms, diagnosis and treatment for their tic-prone furry patients. The clinical signs are largely non-specific in dogs; the humans signature bulls eye lesion does not develop. The treatment process generally mimics the same approach as with humans, except for canines there are commercially available vaccines. Lucky dogs!

While the infection cannot be directly transmitted from a pet to a human, an outside dog or cat may act as a carrier and bring a tick hidden in its fur into a home; once inside, it could bite a human.

While scientists continue working to unravel the mysteries of Lyme disease, remember, when out for a walk in a grassy field, infected ticks are eagerly waiting on the tips of vegetation ready to crawl onto a person or dog and then find a place to bite. Take precautions.

Dr. Jonathan L. Stolz is a retired physician and author of the book Medicine from Cave Dwellers to Millennials.

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Medical Musings: The growing prevalence of Lyme Disease - Daily Press

When the first four civilians travel to the International Space Station April 8 they will be working with a team of University of Central Florida doctors to study how space travel affects the human body, particularly the eyes and brain.

Three faculty physicians at UCF Health, the College of Medicines clinical practice, are collaborating with Axiom Space and two Israeli medical centers Sheba Medical Center and Rabin Medical Center to conduct clinical studies with passengers aboard Axioms private flight that will take four passengers to the International Space Station aboard the SpaceX Crew Dragon. The flight is scheduled to launch from the Kennedy Space Center and should return 10-14 days later. The space explorers received pre-flight testing at UCF Health facilities and will be back for post-flight testing.

The eye study will include the use of high-definition technology unlike any used before to examine the participants eye structure. The brain study is the first of its kind in space. These studies represent UCFs first human subject space studies.

Its a historic moment for space exploration with civilians going to the ISS and for UCF, says Deborah German, vice president for Health Affairs and founding dean of the College of Medicine. These two studies are just the beginning. We have several more to come. Its not just about exploring. What we find will contribute to keeping space explorers safe and finding new treatments here at home.

Its All About the Eyes

The first study, a collaboration between Gal Antman, ophthalmologist from Rabin Medical Center in Israel and UCF Health ophthalmologist Mehul Patel, will examine how the microgravity environment of space affects the structure and function of the eye in a condition called spaceflight-associated neuro-ocular syndrome or SANS that typically occurs in astronauts. The most commonly reported symptom of SANS experienced by astronauts is decreased near vision.

In a microgravity setting, one of the theories is that there is fluid buildup and congestion inside of the orbit, which is the bony space in which our eyeballs rest, Patel says. And so, if there is a buildup of fluid even in short duration flights, that exerts pressure on the eyeball which changes how blood enters the eye and leaves the eye and the actual shape of the eye.

The study includes a range of pre-and post-flight eye exams using a noninvasive approach called optical coherence tomography angiography with the comprehensive imaging device called the Spectralis HRA+OCT2 on loan to UCF from Heidelberg Engineering in Germany. This is the first space eye study that will benefit from this kind of detailed imaging.

All prior studies have used MRIs and other ways to image the back of the eye with photos, Patel says. But this newer OCTA technology can be compared to a 4K or 8K TV and those high definition cameras that are allowing you to see greater depth and clarity. So, we can now do something similar in the back of the eye, to really look at detail and definition of blood flow and vascular changes in the back of the eye.

The Brain and Alzheimers

The second study is a collaboration between Professor Yael Mardor and physicians Itzik Cooper and Harel Baris from the Sheba Medical Center, Israel and UCF physicians Joyce Paulson and Ali Rizvi. The study will examine how space travel affects the structure of the blood-brain barrier (BBB). The barrier is a semipermeable coating around the brain that acts as a filter to prevent harmful toxins or pathogens carried in our blood from getting into the brain.

While the barrier has a protective function, it can also filter out or restrict beneficial substances like therapeutic drugs. Researchers are hoping the barrier can be altered through microgravity to allow better absorption of medications that treat neurodegenerative diseases, like Alzheimers.

The civilian astronauts will undergo pre- and post-flight evaluations (including MRIs) to see if there are changes in the BBB.

If there are any changes, Rizvi says, the end goal is to see whether the blood-brain barrier can be temporarily altered by exposing patients to microgravity either in space or simulated on Earth to facilitate the treatment of diseases like Alzheimers.

This is the first blood-brain barrier study to be conducted on human subjects during space travel at the cellular level.

UCF is grateful for this opportunity to collaborate on this project to help enhance the treatment of neurodegenerative diseases, Paulson says. Right now, there are limitations in terms of what we can do to help these patients. Neurodegenerative diseases are not only difficult to treat, but they are also very progressive and impacts not only the patients but their caregivers as well, so studies like these are very important.

The researchers see these studies as an important step in providing new treatments on earth.

The innovative breakthrough in this study lies not only in the specific research questions and methods but in the creativity of referring to the physiological impacts of exposure to microgravity as holding a therapeutic potential- which holds a promise for harnessing space endeavors to other medical applications and healthcare innovation, says Baris, director of the ARC Space Lab at Sheba Medical Center. We are confident that the collaborations on these studies will pave the way for further shared efforts and enable our clinicians to provide better healthcare, for all human, either in space or on Earth.

Sheba Medical Center is the largest hospital system in Israel and Newsweek has ranked it in the top 10 internationally.

Israeli astronaut Eytan Stibbe has completed all pre-flight testing and will return for post-flight testing at UCF Healths Medical City location and UCF Lake Nona Hospital, the medical schools partnership hospital with HCA Healthcare.

I am excited to be able to participate in these research studies and contribute to medical knowledge for future generations, Stibbe said as he began testing at UCF days before being quarantined before the flight.

The UCF-affiliated studies are just two in of many experiments being conducted during the mission.

The UCF College of Medicines Department of Clinical Trials, under the direction of Amoy Fraser, is leading the trials. Fraser says more space flights studies are under negotiation.

The medical schools research expertise and its Medical City location , close to an international airport and the space center make us an optimal partner for medical space research, Fraser says.

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UCF Part of Historic Civilian Space Flight to the International Space Station - UCF

New findings suggest fenofibrate use was associated with a decreased risk of progression from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) and vision-threatening diabetic retinopathy (VTDR), but not diabetic macular edema (DME) alone.

Additional clinical trials may be necessary to determine if these associations are representative of a causal relationship between fenofibrate use and reduced risk.

Our positive association for progression to PDR coincides with results of previous clinical trials and adds new information with regards to the impact on DME, wrote study author Brian L. VanderBeek, MD, MPH, MSCE, Scheie Eye Institute.

Previous research including the ACCORD-EYE study showed reduced progression of diabetic retinopathy severity, but did not address the thresholds of DME or PDR. In contrast, the FIELD study showed reduced laser treatment of DME and PDR with fenofibrate use, but mixed results in the overall progression of diabetic retinopathy.

Accordingly, there is interest in the potential role of fenofibrate in diabetic retinopathy care, with ongoing randomized clinical trials taking place through the DRCR Retina Network.

The current study aimed to further assess the association between fenofibrate use with diabetic retinopathy progression using medical claims of all beneficiaries in a commercial and Medicare administrative database.

Study cohorts were created from all patients with NPDR 18 years or older from who had laboratory values from January 2002 - June 2019. Criteria for exclusion consisted of any previous diagnosis of PDR, DME, proliferative vitreoretinopathy, or treatment used in the care of VTDR.

The main outcomes were identified as a new diagnosis of VTDR or DME and PDR individually, defined by International Classification of Diseases or Current Procedure Terminology codes. Additionally, a time-updating model for all covariates was used in multivariate Cox proportional hazard regression to determine the hazards of progressing to VTDR.

Investigators included a total of 5835 fenofibrate users at baseline with a mean age of 65.3 years (3564 [61.1%] male patients; 3024 [51.8%] White patients) in the analysis. Moreover, they included 144,417 fenofibrate nonusers, with a mean age of 65.7 years (73,587 [51.0%] male; 67,023 [48.4%] White) in the analysis.

In the observation period, data show 27,325 (18.2%) patients progressed to VTDR, 4086 (2.71%) progressed to PDR, and 22,750 (15.1%) progressed to DME.

After controlling for covariates, Cox model results showed the association between fenofibrate and a decreased risk of VTDR (hazard ratio, 0.92 [95% CI, 0.87 - 0.98]; P = .01) and PDR (hazard ratio, 0.76 [95% CI, 0.64 - 0.90]; P = .001).

However, no association was observed on development of DME (hazard ratio, 0.96 [95% CI, 0.90 - 1.03]; P = .27).

Our findings offer further hope that the DRCR Retina Network clinical trial will prove beneficial for progression to PDR but some concern for those who are hoping for reduction in DME incidence, VanderBeek concluded.

The study, Association of Fenofibrate Use and the Risk of Progression to Vision-Threatening Diabetic Retinopathy, was published in JAMA Ophthalmology.

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Fenofibrate Use May Reduce Progression to Vision-Threatening Diabetic Retinopathy - MD Magazine

PART 1: Life and struggles of migrants, aid workers

Driving an hour from the Tucson, Arizona, airport to the Mexican border, you go through miles of mountains and desert that in the dead of winter appear dark and ominous. Occasionally you see signs for a town -- Rio Rico, Patagonia, Tubac carved out of the terrain.

But for the hundreds of thousands of migrants from Central America and Mexico stuck in the state of Sonora, Mexico, the desert is often the only way out and into the U.S. And it can be treacherous.

In mid-February, I spent a week in Nogales, Arizona, with Jesuits who run the Kino Border Initiative in the other Nogales, across the border in Sonora.

Jesuit seminarian Kieran Halloran, 29, who just left St. Peters Prep in Jersey City after two years of teaching, is spending his third year of regency, or apostolic work, at Kino working with migrants. Reading and hearing so much about issues at the border, I decided to visit him and see for myself.

The suffering and desperation along with the daily heroism of those devoted to help -- are real and ever-present.

As an example, at dinner with the Jesuit community in Arizona one evening, seminarian Victor Yanez received a phone call from a border rescue group that they were on their way to retrieve a man from Mexico who was trying to get into the U.S. and became disoriented.

Nighttime temperatures in the desert are cold and although the stars are so bright you think you can reach up and grab one, the sky is very dark. The migrant was lucky his cell phone worked and he could reach his family, who called the rescue operation, and that they could locate him.

He was also lucky he survived; many do not. Bodies and bones, KBI staff told me, are routinely discovered in the desert. Against the wishes of the U.S. Border Patrol, activists regularly traipse through the desert in daylight and leave jugs and bottles of water along with blankets in what appear to be some well-traveled paths so migrants would have some relief.

But providing relief has become a monumental task.

In the last 40 years, the U.S. government has been tightening immigration policies and millions of migrants, even those seeking asylum for life-threatening situations, have found themselves in limbo at the border. Then-President Trump, through White House immigration adviser Stephen Miller, enacted harsh measures, including Title 42, which requires that migrants seeking asylum remain in Mexico until their cases are heard, which could take months or years. Perhaps as many as 200,000 people hoping to immigrate to the United States remain in the Nogales, Mexico, vicinity.

On April 1, the Biden administration announced plans to finally end Title 42 restrictions starting May 23.

More welcome news had come last month when the Biden administration announced a new policy through which some migrants seeking asylum will have their claims heard and evaluated by asylum officers instead of immigration judges, cutting down the massive backlog of applications.

More than two-thirds of the 11,015 migrants who arrived at KBI last year reported violence or persecution as the main reason for migrating, the organization reports.

And the harshness of life on the Mexican side of Nogales was chronicled in a remarkable 2021 book, Voices of the Border (Georgetown University Press), edited by Tobin Hansen and Sister Maria Engracia Robles, KBI Mexicos director of education.

Robles is the superior of the Missionary Sisters of the Eucharist in Sonora and spent years listening to and transcribing migrants stories of wanting a better life but being stymied by U.S. policies going back to the 1980s. While Trump was a megaphone for hate, even President Obama was deporting people at record numbers.

Maras, or gangs, rule much of Mexico and they demand payment to escape via train. But once on the train, migrants are targeted again for hundreds of U.S. dollars, which most do not have, to continue the journey. Those who refuse or cannot pay would be thrown off into the train tracks, decapitated or attacked with a machete, the VOB book detailed.

From 1998 to 2020, the authors write, more than 7,500 people lost their lives while attempting to cross the treacherous U.S.-Mexico border due to heat stroke, dehydration, hyperthermia and drowning.

Some have been killed in incidents with Border Patrol. On the Mexican side of the border, Halloran and I stopped by a huge painting of 16-year-old Jose Antonio Elena Rodriguez, who was shot and killed 10 years ago by a USBP agent who fired into Mexico from the American side. The agent claimed the boy threw rocks at him, putting the agents life in danger. Mysteriously the camera video disappeared and the agent was acquitted of murder at trial in Tucson.

FLEEING VIOLENCE

Among the 50 migrants in the shelter when I was there were people from Central American countries fleeing gang violence and threats on their lives. KBI protects them while providing legal aid to expedite their asylum claims.

The seriousness of their situations is evident in the fact that the new KBI building, open since 2020, has no outdoors space where the shelter residents can go out in the sun even though there is endless land around it. On the land adjacent, men who appear to be squatters wander. Yanez calls them the Mafia, who spy on people coming to and from the border crossing and are part of an underworld of people who take advantage of desperate migrants.

As a priest, I had free reign at the shelter but as a journalist could not interview the migrants there. KBIs policy is not to revictimize the migrant, said Yanez.

We work with each migrant how to tell his or her story in a fashion that looks toward the future, he told me.

That is the role of Gia Del Pino, 31, KBI director of communications for the last eight months.

Migrant justice is my calling, said the Ph.D. candidate at the University of Arizona in Tucson, a beautiful campus I visited. She is a child of Cuban and Venezuelan immigrants.

My closest contact to these protected migrants was sitting in on the ESL classes given by Sister Marlita Henseller in a back section of the shelter. Shes on a one-year sabbatical volunteering at KBI. A Wisconsin Franciscan Sister of Christian Charity for 58 years, she represents for me the best of the hundreds of women religious I have met in my years as a priest. They started out as school teachers or working in Catholic institutions but then embraced the Vatican II spirit to get out into the world and minister to the poor.

Henseller learned Spanish in Bolivia over five months and then served as a missionary in Peru for 12 years.

Wanting to go to Sonora, she said, I told my provincial I wanted to hug Spanish babies. And surely her warm, friendly style embraces migrant women and children as she guides them to learn English.

The mothers are young, but their children seem to pick up the English quicker. Sometimes, the younger children are restless and distract the group, but Sister takes it in stride and shows humor.

The international charity Save the Children staffs a large, colorful education center at KBI and works with the children to keep up with studies and also provide them with some activities.

COMEDOR

While KBI now has many components, it is commonly referred to as the comedor, or dining room, after its initial mission to feed migrants.

As soon as you enter the large central space, your eyes are drawn to a huge mural of the Last Supper on the far wall, a painting of actual KBI migrants, staff and volunteers done by Wenceslao Hernandez, a migrant who has established himself as a Sonora, Mexico, artist. Its so realistic you think it is a photo, but it also captures what continues to be KBIs main mission: feeding the hungry.

On any given day pre-pandemic, KBI would serve anywhere from 100 to 900, estimated Joanna Williams, 30, executive director for the last year, though employed there for seven.

The current building opened Feb. 12, 2020, right before COVID closed it down, and it has slowly been building up its clientele and services. Food service is now to-go.

My first day there I was part of the morning food serving team dishing out string beans mixed in with scrambled eggs and then rice, once the eggs were finished.

Henseller checked in the migrants, mostly women with children and some men.

First, soup, then I would be next. They would say in Spanish how many people they would feed that day and I would scoop that number. Then they could have mole, chicken pieces in chocolate sauce. They help themselves to some drink and bread and then go on their way.

Its very eye-opening to see these young mothers with young children following behind them often clinging to their blouse. I asked each child his or her name and made faces at them to make them smile. The special treatment they receive blunts the harshness of daily life they face.

In the month of February, KBI served 8,374 meals. While the number of people they feed now is lower than pre-pandemic, the numbers grow daily.

These migrants are staying in Sonora shelters while their asylum cases are processed, Halloran said.

Without KBI, where would they be able to get as much delicious and nutritious food?

The prep kitchen is always a beehive of activity. After serving, the food for the next days meal is prepped and I was assigned chopping a huge bin of onions along with Kevin Miller, a 28-year-old Californian discerning whether he wants to enter the West Coast province of Jesuits this summer, and Chris Nguyen, 45, a Jesuit seminarian and a regent in campus ministry at the University of California, San Diego.

Four Mexican Missionary Sisters of the Eucharist oversee the kitchen and food prep. They get lots of help from recent college graduates and some gap-year students who spend anywhere from two months to a year living in community in a house nearby in Mexico.

Courtney Smith was next to me on the food serving line. A graduate of Georgetown, the Connecticut native is spending one year at KBI to see the migrant experience first-hand so she can go into work, perhaps in D.C., writing policy for a member of Congress or an immigrant advocacy group.

ADVOCACY

Indeed, advocacy is a big part of KBI mission to promote U.S./Mexico border and immigration policies that affirm the dignity of the human person and a spirit of bi-national solidarity.

To achieve this goal, they provide direct humanitarian assistance, accompaniment with migrants, social and pastoral education, networking to research and transform local, regional, and national immigration policies, according to their website.

In fact, Executive Director Williams credits the decision to end Title 42 in part to the persistence and courage of asylum seekers here in Nogales who have shared their stories and illustrated the suffering that the policy has created.

Yanez, 31, has the job of directing KBIs operations.

A Jesuit regent, who just spent two years at Fordham studying philosophy and also receiving a M.B.A., would typically just volunteer. But his abilities made him suitable to fill a valuable role.

What leaves him completely joyful, he said, is that KBI can provide food and services and allow migrants to acknowledge their own dignity.

He made a coup this year by attracting KBIs first full-time medical doctor. Mexican native Dr. Obed Ruiz, 34, has been a doctor for four years. He sees perhaps a dozen or so migrants each day and said, They have lots of needs.

He treats for dehydration, wounds, blisters and also sees victims of violence. Many, he said, have psychological problems from abuse in so many forms.

The shelter, which accommodates up to 150 individuals, is on the far side of the KBI building. They sleep in bunk beds in several large areas where there are also showers and restrooms. There is also an isolation section for individuals with COVID.

One of the most colorful people I met during my trip was Jesuit Peter Neeley, the superior of the Jesuit community and one of KBIs founders. A Jesuit for 50 years, he reminded me of the many Jersey City Jesuits Ive known, except he wears a cowboy hat and sports a handlebar mustache. Like the Jesuits in Hudson, Neeley came to the order while its 28th Superior General, Pedro Arrupe, moved the Society of Jesus in the late 1960s to live religious life through the prism of social justice.

We moved away from Christ the King to Christ the liberator, Neeley said.

WHO WAS EUSEBIO KINO?

In a way he is a lot like the namesake of the Border Initiative: Eusebio Francisco Kino, from Segno, Tirol, now Italy. The Spanish king in the late 17th century sent this Jesuit priest to evangelize through missions in the Pimera Alta region, now divided between the Mexican state of Sonora and Arizona. Kino was quite successful and even the Spanish military reported to him. Named after Kino is a parkway road, a sports complex and even Kino Springs.

Neeley lives with four seminarians half his age -- Halloran, Yanez, Jarrett Ornelas, who was away while I was there, and Max Landman, 35, a Texas diocesan priest transitioning into the Jesuits. All of them speak Spanish and relate well to each other, sharing in cooking dinner and taking on community tasks. They celebrate daily Mass in a small chapel in their house usually right before dinner.

We are doing what Christ wants, Neeley told me, not to be a prophet, but to live by example.

U.S. Customs and Border Protection vehicles are positioned in Nogales, Arizona, under a pedestrian bridge used by documented commuters. (Rev. Alexander M. Santora photo)

PART 2: All they want is a better life

President Trump used to claim that U.S. border agents supported his draconian immigration policies, and migrants routinely report abuse by USBP. But there are agents, I found, who do their job without malice.

One day, I took a bike ride through downtown Nogales, Arizona, and could not go any further since I reached the elaborate crossing where people, mostly Americans, legally walk to and from Mexico for work. Obviously, they have papers.

During a shift change, I encountered an agent when he disembarked from a USBP van to stretch. He told me he was watching the people exiting on the Arizona side, saying migrants trying to illegally enter the U.S. sometimes dress like commuters and flee into the country.

Hes worked for Border Patrol through three U.S. presidents. He himself is a migrant and now lives a few towns north of Nogales in an upper-middle-class suburb.

He seemed very caring and sensitive. Just that day, he said, he stumbled across a bin of old boots he intended to bring to the job and give to migrants who need them. He knows the agents have a job to do but seemed aware how Trump demonized their work and their image.

Morale is low, he admitted.

I told him I was a Catholic priest and he said he was Catholic and that might have colored what he told me: We feel sorry for the migrants because we know all they want is a better life for their families.

Shops and supermarkets in Nogales, Arizona, have a large selection of Catholic statuary. (Rev. Alexander M. Santora photo)

PART 3: Mexican, Catholic influences strong in Nogales

When I visit a new area, I like to explore the neighborhoods, so I spent several periods during the week walking and biking around Nogales, Arizona. I stumbled on the local library where I could read the Arizona Daily Star and some weeklies.

Nogales has been hit hard by the pandemic with many storefronts shuttered and others trying to hang on. I kept passing a closed store that sold Mexican artifacts. Finally, I found it open, met the owner and learned it is actually a business that sells Mexican items to other businesses for design and decoration.

The owner told me hes been there 23 years and might open a small retail space to attract more customers. Business is bad, he lamented.

Nearby Food City, the equivalent of our Shop-Rite or Acme, has a very popular bakery. Almost all the staff and patrons are Spanish-speaking. As I walked throughout, I noticed that their healthy alternatives, though, were minimal with little choices for no-sugar or low-fat options. But they have two aisles of religious statuary and candles.

Across the street and up the hill is Sacred Heart Church, which I attended on Sunday morning along with about 200 people, again mostly Hispanic.

I later crossed the tracks, which seem to bring freight trains to and from the Mexican border and their box cars seemed endless. It reminded me of what Jersey City had been in its industrial heyday when boats would dock on the Hudson waterfront and trains would transport goods to the heartland.

The Rev. Alexander Santora is the pastor of Our Lady of Grace and St. Joseph, 400 Willow Ave., Hoboken, NJ 07030. Email: padrealex@yahoo.com; Twitter: @padrehoboken.

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Beyond the Wall: Eye-opening visit to U.S.-Mexico border | Faith Matters - NJ.com

FLORHAM PARK, N.J., April 01, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on Tuesday, April 12, 2022 at 9:30 a.m. ET.

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Phathom Pharmaceuticals to Present at the 21st Annual Needham Virtual Healthcare Conference

MIAMI, April 01, 2022 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced a two-day summit hosted by the B. Riley Securities’ Healthcare Equity Research team, that will feature multiple programs from Fortress’ diversified pipeline. The events will be held virtually on Tuesday, April 5, and Wednesday, April 6, 2022, beginning at 1:00 p.m. ET each day.

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Fortress Biotech Announces Virtual Two-Day R&D Summit Hosted by B. Riley Securities on Tuesday, April 5 and Wednesday, April 6, 2022

ANAHEIM, CA, April 01, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today provided a year-end business update for 2021 and reported on recent corporate developments.

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BioCorRx Provides 2021 Year-End Business Update

SAN DIEGO, April 01, 2022 (GLOBE NEWSWIRE) -- Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that single ascending dose and multiple ascending dose data from the Phase 1 study evaluating LP352 in healthy volunteers will be presented at the American Academy of Neurology (AAN) Annual Meeting being held in person April 2–7, 2022, in Seattle, WA, and virtually April 24–26, 2022.

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Longboard Pharmaceuticals to Present Phase 1 Data for LP352 at the American Academy of Neurology Annual Meeting

Presentations highlight potential of losmapimod to slow or stop progression of FSHD

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Fulcrum Therapeutics® Announces Multiple Presentations on FSHD at the American Academy of Neurology’s Annual Meeting

LAS VEGAS, April 01, 2022 (GLOBE NEWSWIRE) -- Healthy Extracts Inc. (OTCQB: HYEX), a leading innovator of clinically proven plant-based products for heart and brain health, reported results for the fourth quarter and full year ended December 31, 2021.

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Healthy Extracts Reports Fourth Quarter and Full Year 2021 Results

BOSTON, April 01, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that data from its PRAX-944 essential tremor (ET) program will be presented at the upcoming 2022 American Academy of Neurology (AAN) Annual Meeting, which will take place in Seattle, Washington from April 2 – 7, 2022 and virtually from April 24 – 26, 2022. Abstracts can be accessed on the AAN meeting website.

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Praxis Precision Medicines to Present Data from PRAX-944 for Essential Tremor at 2022 American Academy of Neurology Annual Meeting

NEW YORK, April 01, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA.

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Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA