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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…
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…
HORA-PDE6b Gets FDA Rare Pediatric Disease Status
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…
FDA Approves SB-007 for Stargardt Disease
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…
Atsena Completes XLRS Gene Therapy Trial Dosing
Atsena Therapeutics has successfully completed dosing in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating the subretinal delivery of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). The study represents an important step forward in developing…
ACELYRIN Halts Izokibep Development | OBN
ACELYRIN has announced that the Phase 2b/3 clinical trial evaluating izokibep for non-infectious, non-anterior uveitis did not achieve its primary endpoint. The trial results did not demonstrate a statistically significant improvement in time to treatment failure versus placebo. Consequently, the…