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Nov 20, 2025 12:00 PM

Regeneron Wins FDA Nod For Eylea HD With Reduced Injection Schedule For Patients With Vision Loss

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea HD (aflibercept) Injection 8 mg for patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.

RVO is a blockage in one of the veins that drain blood from the retina, causing blood and fluid to leak and potentially leading to vision loss.

The FDA also approved a monthly dosing option for some patients who may benefit from resuming this dosing schedule across approved indications: wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.

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