Regeneron’s EYLEA HD 8 mg Receives FDA Priority Review for Expanded Use

Regeneron Pharmaceuticals announced that the U.S. FDA has accepted a supplemental Biologics License Application (sBLA) for EYLEA HD (aflibercept) Injection 8 mg for Priority Review. The review pertains to two key updates: the treatment of macular edema following retinal vein occlusion (RVO) and the option for monthly dosing in all currently approved indications.

If approved, EYLEA HD would become the only treatment for RVO allowing an extended dosing interval of up to every 8 weeks after the initial loading doses. Current anti-VEGF therapies for RVO, including the standard EYLEA 2 mg, are limited to monthly dosing.

The sBLA is supported by the Phase 3 QUASAR trial, which showed that EYLEA HD administered every 8 weeks provided non-inferior visual gains compared to monthly 2 mg dosing. The safety profile was consistent with previous findings, with intraocular inflammation rates and other adverse events remaining low.

The FDA’s decision is expected by August 19, 2025. Regeneron notes that the approval could offer physicians and patients greater flexibility in dosing, potentially reducing treatment burden.

EYLEA HD is already approved in the U.S. for wet AMD, diabetic macular edema (DME), and diabetic retinopathy (DR), and is jointly developed with Bayer. The new indication and dosing flexibility, if approved, would mark another step forward in Regeneron’s ophthalmology portfolio.