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

Author: Vandana Singh | November 20, 2025 11:52am

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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“Eylea HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies. And with the addition of a monthly dosing option for all four approved Eylea HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs,” said George Yancopoulos, Regeneron’s co-founder, board co-chair, president and chief scientific officer.

The FDA approval is based on data from the Phase 3 QUASAR trial, which evaluated the efficacy and safety of Eylea HD compared with Eylea (aflibercept) Injection 2 mg in patients with RVO.

QUASAR met its primary endpoint at 36 weeks, with Eylea HD patients dosed every 8 weeks (after either 3 or 5 monthly doses) achieving non-inferior visual acuity gains compared to those receiving Eylea dosed every 4 weeks.

The Eylea HD results were consistent across patients with branch retinal vein occlusions and those with central retinal or hemiretinal vein occlusions.

Regarding the Eylea HD pre-filled syringe (PFS), Regeneron continues to coordinate with Catalent Indiana, LLC (part of Novo Nordisk A/S) as it works to resolve the outstanding issues identified during a July 2025 FDA general site inspection (not specific to Eylea HD).

As previously disclosed, Regeneron also plans to submit to the FDA an application to include an alternate PFS manufacturing filler for the Eylea HD BLA by January 2026.

Price Action: REGN stock is up 6.26% at $746.72 at the last check on Thursday.

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