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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 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…

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…

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…

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,…

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…

2024 Recap is here! Click to review:Top 10 Breakthroughs in Ophthalmology Research In the fast-evolving landscape of ophthalmology research, 2023 has proven to be a pivotal year marked by groundbreaking discoveries and innovation. From revolutionary cell replacement therapies to novel…

eyeDNA Therapeutics, a newly created subsidiary of Coave Therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) for HORA-PDE6b, the company’s novel gene therapy designed to treat inherited retinal dystrophy…

The FDA has cleared an Investigational New Drug (IND) application for SB-007, an adeno-associated viral (AAV) vector gene therapy targeting the root genetic cause of Stargardt disease, according to a press release from SpliceBio. Addressing Stargardt Disease Across All ABCA4…

A collaborative team from the University of Southern California (USC) and the University of Utah has been awarded a $2.7 million grant from the National Institutes of Health (NIH) to investigate how retinitis pigmentosa (RP) disrupts the visual wiring in…