National Eye Institute
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private, Subsidiary
- Established
- 1968-01-01
- Employees
- 101
- Market Cap
- -
- Website
- http://www.nei.nih.gov
FDA Grants IND Clearance for Immunoglobulin Eye Drops to Treat Dry Eye Disease
• The FDA has granted Investigational New Drug clearance for immunoglobulin eye drops (SLG-100/GRF312), developed by Selagine and Grifols, to treat dry eye disease in upcoming Phase II clinical trials.
• The novel treatment offers broad-spectrum anti-inflammatory and immunomodulatory properties, potentially providing mechanistic superiority over current narrow-spectrum therapies that primarily target T-cell inflammation.
• A first-in-human pilot trial demonstrated significant reduction in dry eye symptoms with no difference in tolerability or adverse events compared to vehicle, showing promise for the over 100 million people affected globally.
Repurposed Blood Pressure Drug Shows Promise for Treating Inherited Retinal Diseases with Sex-Specific Benefits
• NIH researchers have discovered that reserpine, a decades-old blood pressure medication, can protect photoreceptor cells from degeneration in inherited retinal dystrophies regardless of the specific genetic mutation involved.
• The drug showed particularly strong protective effects in female subjects compared to males in a rat model of retinitis pigmentosa, suggesting potential for sex-specific therapeutic approaches in treating blinding diseases.
• Reserpine offers advantages as a small molecule therapy that can be delivered directly to the eye at low doses, potentially providing a faster path to treatment than gene-specific therapies for the more than 1,000 mutations that can cause inherited retinal diseases.
NIH Researchers Develop Eye Drops That Could Slow Progression of Retinitis Pigmentosa
• Researchers at NIH have developed eye drops containing small peptides derived from pigment epithelium-derived factor (PEDF) that successfully slowed vision loss in animal models of retinitis pigmentosa.
• The peptide formulations, particularly H105A, preserved up to 75% of photoreceptors in treated mice and maintained functional vision, while reaching the retina within 60 minutes of application without toxicity.
• While not a cure, these PEDF-based eye drops show promise for treating various degenerative retinal diseases, including retinitis pigmentosa and dry age-related macular degeneration, with researchers now planning human clinical trials.
FDA Grants RMAT Designation to Novel Cell Therapy for Dry AMD Treatment
• Luxa Biotechnology's RPESC-RPE-4W cell therapy receives FDA's Regenerative Medicine Advanced Therapy designation for treating dry age-related macular degeneration, based on promising Phase 1 data.
• The innovative treatment utilizes adult retinal pigment epithelial stem cells to generate replacement RPE cells, addressing progressive vision loss in AMD patients.
• Initial safety and efficacy data from the first cohort of six patients will be presented at the 77th annual Wills Eye Conference in Philadelphia in March 2025.
Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment
• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss.
• The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections.
• FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.
BLINK2 Study: Myopia Control Benefits Persist After Multifocal Lens Discontinuation in Teens
• The BLINK2 study demonstrated that the myopia control benefits of multifocal contact lenses in teenagers persist even after discontinuing their use, with eye growth returning to age-expected rates.
• Axial elongation increased slightly after switching to single-vision lenses, but the overall rate of eye growth remained consistent with age-related expectations, indicating no rebound effect.
• Starting myopia control treatment with multifocal lenses at a younger age and continuing until the late teenage years is a promising strategy for durable benefits.
• The high-add multifocal lens group maintained shorter eyes and less myopia compared to the medium-add and single-vision groups, highlighting the long-term efficacy of early intervention.
Aurion Biotech's AURN001 Shows Promise in Phase 1/2 Trial for Corneal Edema
• Aurion Biotech's AURN001, an allogeneic cell therapy, demonstrated statistically significant improvement in visual acuity in patients with corneal edema in a Phase 1/2 trial.
• The high-dose AURN001 arm showed that 50% of patients achieved a ≥15-letter improvement in best-corrected visual acuity (BCVA) at 6 months, compared to 14.3% in the Y-27632-only arm.
• Key secondary endpoints, including change in BCVA and central corneal thickness, also showed statistically significant improvements in the high-dose AURN001 arm.
• AURN001 combines neltependocel (allogeneic human corneal endothelial cells) and Y-27632 (a rho kinase inhibitor) and is intended as a one-time anterior chamber injection.
Acelyrin's Lonigutamab Shows Promise in Phase 2, Phase 3 Program Design Announced for Thyroid Eye Disease
• Acelyrin's lonigutamab demonstrated clinically meaningful improvements in Thyroid Eye Disease (TED) symptoms, including proptosis, CAS, and diplopia, in Phase 2 trials.
• The Phase 3 LONGITUDE program, consisting of two global trials, is set to begin in Q1 2025, evaluating lonigutamab's safety and efficacy with topline data expected in H2 2026.
• Lonigutamab, a subcutaneous anti-IGF-1R monoclonal antibody, showed a favorable safety profile with no reported cases of hearing impairment, hyperglycemia, or menstrual disorders.
• Acelyrin's strategic focus shifts to lonigutamab after izokibep fails in Phase 2b/3 uveitis trial, with existing cash resources projected to last through mid-2027.
ARPA-H Funds Multi-Institutional Consortium to Cure Blindness Through Eye Transplantation
• The University of Colorado Anschutz Medical Campus will receive up to $46 million from ARPA-H to advance vision-restoring human whole eye transplantation.
• The project aims to achieve the first successful vision recovery in six human whole eye transplants by 2030, addressing optic nerve regeneration challenges.
• The multi-disciplinary team includes experts from Johns Hopkins, University of Wisconsin, and the National Eye Institute, focusing on innovative technologies.
• The Foundation Fighting Blindness will strategically align the consortium's progress with program requirements, driving advancements in treating blinding diseases.
UND Research Team to Evaluate VR Therapy for Pediatric Amblyopia in NIH-Funded Clinical Trials
• The University of North Dakota (UND) research team has been approved to conduct clinical trials for the Pediatric Eye Disease Group (PEDIG), focusing on innovative treatments for childhood eye conditions.
• The trials will assess the effectiveness of virtual reality (VR) headsets as a novel approach to treating amblyopia, also known as lazy eye, in children aged 4 to 12.
• These PEDIG studies, funded by the National Eye Institute (NEI) and the National Institutes of Health (NIH), aim to compare VR therapy with traditional eye patching for amblyopia treatment.
• The research could potentially change the standard of care for amblyopia, offering a more engaging and effective alternative to conventional methods.
Low-Dose Antiviral Therapy Reduces Risk of Eye Disease from Shingles
• Long-term, low-dose valacyclovir reduces the risk of new or worsening eye disease by 26% in patients with herpes zoster ophthalmicus (HZO).
• The Zoster Eye Disease Study (ZEDS) found a 30% reduction in flare-ups at 12 months and 28% at 18 months with antiviral therapy.
• The treatment also shortened pain duration and decreased the need for medications like pregabalin and gabapentin.
• Experts emphasize shingles vaccination with Shingrix for adults 50 and older, and immunocompromised adults 19 and older.
Study Reveals Heightened Depression Risk in Retinitis Pigmentosa Patients, Particularly Among Young Adults
• A large-scale Korean study found that patients with retinitis pigmentosa have a 19% higher risk of developing depressive disorders compared to the general population.
• Young adults in their 20s showed the highest risk elevation, with women having a 55% higher risk and men showing a 44% increased risk of depression after RP diagnosis.
• The research indicates that approximately 35% of RP patients may experience depressive disorders, highlighting the urgent need for emotional and social support interventions.
UAMS Awarded $2.2 Million Grant to Investigate Efferocytosis in Retinopathy
• The University of Arkansas for Medical Sciences (UAMS) has received a $2.2 million grant from the National Eye Institute (NEI).
• The grant will fund research into how modulating the immune response through efferocytosis can benefit patients with retinopathy.
• Dr. Abdel Fouda's lab will lead the study, exploring methods to enhance myeloid cell-mediated efferocytosis in treating retinopathy.
• The research aims to develop new therapies for ischemic and trauma-induced retinopathy by understanding efferocytosis' role.
RNF114 Protein Identified as Potential Target for Cataract Drug Development
• Researchers have identified the RNF114 protein as a potential target for non-surgical cataract treatment, offering a possible alternative to surgery.
• The study, conducted on ground squirrels and rats, demonstrated that RNF114 is significantly elevated during the reversal of cold-induced cataracts.
• Pretreatment with RNF114 led to rapid clearing of cataracts in rat lenses exposed to low temperatures, suggesting a novel therapeutic approach.
• These findings provide proof-of-principle for inducing cataract clearance in animals, warranting further research into targeted protein degradation strategies.
FDA Asked to Scrutinize US Pharma's Clinical Trials with PLA Affiliates
• A bipartisan group of U.S. representatives has requested the FDA to provide information on clinical trials conducted by major U.S. biopharmaceutical companies in collaboration with entities affiliated with China's People's Liberation Army (PLA).
• The representatives are concerned about potential technology transfer and intellectual property risks associated with these collaborations, especially given the PLA's Academy of Military Medical Sciences being on the Commerce Department's Entity List.
• The FDA is asked to disclose how many PLA-affiliated facilities it has reviewed for clinical trial work and whether it has ever notified U.S. companies about conducting studies with the PLA or in regions with ethical concerns.
• The request follows previous instances where the FDA declined oncology treatment approvals based solely on clinical trial data from China, suggesting a need for similar scrutiny in cases involving PLA collaboration.
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