FDA Approves Eylea HD for Retinal Vein Occlusion; Expands Dosing Intervals Across Indications

The U.S. Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8 mg from Regeneron Pharmaceuticals for the treatment of macular edema following retinal vein occlusion (RVO). The approval allows dosing intervals of up to every 8 weeks following an initial monthly dosing phase.

The FDA also expanded Eylea HD’s label to include a monthly (every 4-week) dosing option across all of its approved indications, which now include wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.

“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,” said George D. Yancopoulos, MD, PhD, Co-Founder, Board Co-Chair, President, and Chief Scientific Officer at Regeneron. “These approvals further position Eylea HD as a treatment of choice for certain retinal diseases and underscore our commitment to meeting the needs of patients and the retina specialists who treat them.”

Phase 3 QUASAR Trial Supports FDA Decision

The approval for RVO is based on data from the global phase 3 QUASAR trial, which compared Eylea HD (8 mg) with standard Eylea (2 mg). The study met its primary endpoint at week 36, demonstrating:

       • Noninferior visual acuity gains in patients receiving Eylea HD every 8 weeks (after 3 or 5 initial monthly doses) versus those treated with standard Eylea every 4 weeks.

       • Consistent outcomes across patients with branch, central, or hemiretinal vein occlusion.

       • Adverse reactions reported in ≥3% of patients included increased intraocular pressure, blurred vision, cataract, conjunctival hemorrhage, ocular discomfort, and vitreous detachment.

The QUASAR study is being conducted by Bayer in collaboration with Regeneron.

Update on Pre-Filled Syringe Manufacturing

Regeneron provided an update on Eylea HD’s pre-filled syringe (PFS) manufacturing, noting ongoing collaboration with Catalent Indiana, LLC (part of Novo Nordisk A/S) to address issues identified during an FDA site inspection in July 2025. The company plans to submit an application by January 2026 to include an alternate manufacturing filler for the Eylea HD biologics license application.

Updated Dosing Intervals Across Indications

Following this approval, Eylea HD now includes the following dosing intervals:

       • wAMD and DME: Every 8–16 weeks after three initial monthly doses

       • DR: Every 8–12 weeks after three initial monthly doses

       • RVO: Every 8 weeks after 3–5 initial monthly doses

Regeneron noted that some patients in clinical studies did not maintain treatment response when extending intervals and may require a return to monthly dosing.