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NEI Study Reveals Annexin-V’s Role in Retinal Diseases
A recent study led by the National Eye Institute (NEI) has revealed new insights into annexin-V, a key biomarker traditionally used to track apoptosis (programmed cell death) and retinal cell degeneration in eye diseases. Published in the International Journal of…
4DMT Reveals Preclinical Data on TVE Platform
4D Molecular Therapeutics (4DMT) has announced the publication of preclinical data underscoring the capabilities of its Therapeutic Vector Evolution (TVE) platform. The research focuses on the intravitreal R100 vector and the R100-based genetic medicine 4D-150. This groundbreaking study, titled “Design…
Sepul Bio Launches Ultevursen Phase 2b Trial for RP
Sepul Bio has announced the dosing of the first patient in the LUNA clinical study, a Phase 2b trial evaluating ultevursen for the treatment of USH2A-associated retinitis pigmentosa (RP). This milestone represents renewed hope for individuals affected by this debilitating…
Opus Gets FDA SPA for APX3330 Phase 3 Trial
Opus Genetics has announced a key regulatory milestone, securing a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of APX3330. The oral treatment is being evaluated for moderate to…
EYLEA HD Succeeds in Phase 3 RVO Trial
Regeneron Pharmaceuticals has announced that its Phase 3 QUASAR trial evaluating EYLEA HD (aflibercept 8 mg) has met its primary endpoint, marking a significant advancement in the treatment of retinal vein occlusion (RVO). About the QUASAR Trial The QUASAR trial…
Aurion’s AURN001 Shows Positive Phase 1/2 Results
Aurion Biotech has released topline data from its Phase 1/2 clinical trial (CLARA), evaluating AURN001, an allogeneic cell therapy product candidate for treating corneal edema secondary to corneal endothelial dysfunction. These results highlight the therapy’s potential as a groundbreaking treatment…
Global ophthalmic pharmaceutical and medical technology company, Glaukos, to locate multimillion-dollar facility in Cummings Research Park – City of Huntsville (.gov)
Global ophthalmic pharmaceutical and medical technology company, Glaukos, to locate multimillion-dollar facility in Cummings Research Park City of Huntsville (.gov) Source: Author: | Date: 2024-12-19 08:00:00 Source: Author: | Date: 2024-12-19 08:00:00
FDA Clears ViGeneron’s VG801 for Stargardt Disease
The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for VG801, ViGeneron’s novel gene therapy candidate designed to treat Stargardt disease and other retinal dystrophies caused by mutations in the ABCA4 gene. This marks…
Veligrotug Delivers Positive Results in Phase 3 TED Trial
Viridian Therapeutics has announced positive topline results from the Phase 3 THRIVE-2 clinical trial evaluating veligrotug, an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, for the treatment of chronic thyroid eye disease (TED). The trial met its primary and secondary endpoints,…
EMA Backs Celltrion’s Aflibercept Biosimilar
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and marketing authorization recommendation for Eydenzelt, Celltrion’s biosimilar to aflibercept (Eylea). This marks a significant milestone for Celltrion, a South Korea-based biopharmaceutical…