FDA extends target action date for two Regeneron regulatory submissions to Q4 of 2025
August 21st 2025Included is the supplemental Biologics License Application (sBLA) for EYLEA HD seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week dosing across approved indications.
FDA clears IND for Opus Genetics’ OPGx-BEST1 gene therapy for inherited retinal disease
August 19th 2025Best disease, or vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and, in some cases, blindness.