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Glaukos Submits FDA Application for Epioxa Therapy

Glaukos Corporation has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its innovative corneal cross-linking therapy, Epioxa (Epi-on). This next-generation treatment is designed for patients with keratoconus and represents a significant advancement…

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…

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