The FDA has approved Regeneron's Eylea HD (aflibercept) Injection 8 mg for the treatment of macular edema following retinal vein occlusion (RVO). The approval includes dosing intervals of up to every 8 weeks after an initial monthly dosing period.

In addition, the FDA has cleared a monthly (every 4-week) dosing option for Eylea HD across all of its approved indications, which 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 relentless commitment to meeting the needs of patients and the retina specialists who treat them.”

Approval Backed by Phase 3 QUASAR Trial

The FDA’s decision for RVO was supported by data from the global phase 3 QUASAR trial, which evaluated Eylea HD against the standard Eylea (aflibercept 2 mg). The study met its primary endpoint at week 36:

  • Patients receiving Eylea HD every 8 weeks (after 3 or 5 initial monthly doses) achieved noninferior visual acuity gains compared to those treated with Eylea every 4 weeks

  • Positive results were consistent across patients with branch retinal vein occlusion as well as central or hemiretinal vein occlusion

  • Adverse reactions occurring in ≥3% of patients included increased IOP, blurred vision, cataract, conjunctival hemorrhage, ocular discomfort, and vitreous detachment

The QUASAR trial is being executed by Bayer in collaboration with Regeneron.

Manufacturing Update on Pre-Filled Syringe (PFS)

Regeneron also provided an update on the Eylea HD pre-filled syringe, noting continued coordination with Catalent Indiana, LLC (part of Novo Nordisk A/S) to address issues identified in a July 2025 FDA site inspection. The company reiterated its plan to submit an application by January 2026 to add an alternate PFS manufacturing filler to the Eylea HD biologics license application.

Expanded Dosing Intervals Across Indications

Eylea HD now carries the following approved 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 trials did not maintain their response when extending treatment intervals, and may benefit from returning to monthly dosing.