FDA Grants Priority Review for Expanded Eylea HD Use

The U.S. Food and Drug Administration has accepted Regeneron Pharmaceuticals' supplemental Biologics License Application for Eylea HD (aflibercept) Injection 8 mg under Priority Review. The application seeks expanded approval for treating macular edema following retinal vein occlusion (RVO) and for allowing both monthly and up-to-eight-week dosing schedules across approved indications. If approved, Eylea HD would become the first and only RVO treatment that could be administered every eight weeks after an initial monthly dosing period, potentially halving the number of required injections compared to current anti-VEGF therapies. The submission is supported by data from the Phase 3 QUASAR trial, which demonstrated that Eylea HD administered every eight weeks was non-inferior in improving visual acuity compared to standard monthly dosing and had a similar safety profile. The FDA’s target action date is August 19, 2025, following the use of a Priority Review voucher.