The US Food and Drug Administration (FDA) has granted priority review status to Regeneron’s supplemental biologics license application for aflibercept 8 mg (Eylea HD). The application seeks approval for the treatment of macular edema secondary to retinal vein occlusion (RVO) and for expanded use of monthly dosing in existing indications.

If approved, Eylea HD would become the first anti-VEGF therapy indicated for dosing up to every 8 weeks after an initial monthly regimen for RVO, potentially reducing the treatment burden compared to currently approved monthly therapies. RVO is a leading cause of vision loss worldwide, affecting over 28 million people.

The application is supported by data from the phase 3 QUASAR trial, which met its primary endpoint at 36 weeks. In the study, aflibercept 8 mg administered every 8 weeks showed noninferior visual acuity outcomes compared to aflibercept 2 mg (Eylea) given every 4 weeks. The safety profile of Eylea HD was generally consistent with that of the original formulation.

Eylea HD is currently approved in the US for diabetic macular edema, diabetic retinopathy, and neovascular (“wet”) age-related macular degeneration. Regeneron co-develops the drug with Bayer, which holds rights outside the United States.

The FDA’s target action date under the Prescription Drug User Fee Act is August 19, 2025.