Regeneron announces FDA accepted Priority Review sBLA for EYLEA HD

On April 17, Regeneron (REGN) Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion, RVO, and for broadening the dosing schedule to include every 4-week dosing across approved indications. The FDA target action date is August 19, 2025, following the use of a Priority Review voucher. The sBLA is supported by data from across the EYLEA HD clinical program, including the Phase 3 QUASAR trial investigating EYLEA HD in RVO.