Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved EYLEA HD (aflibercept) Injection 8 mg for treating macular edema following retinal vein occlusion (RVO), allowing dosing intervals of up to every eight weeks after an initial monthly series. The FDA also endorsed a monthly dosing option for patients across all approved EYLEA HD indications, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and RVO, offering clinicians greater flexibility in tailoring treatment schedules.
The approval for RVO is backed by results from the Phase 3 QUASAR trial, which met its primary endpoint at 36 weeks. Patients receiving EYLEA HD every eight weeks—after three or five monthly doses—achieved non-inferior visual acuity gains compared to participants treated with the standard 2 mg EYLEA administered every four weeks. The efficacy was consistent across subtypes of RVO, including branch, central and hemiretinal vein occlusion. Common adverse reactions occurring in 3% or more of patients on EYLEA HD included increased intraocular pressure, blurred vision, cataract, ocular discomfort, conjunctival hemorrhage and vitreous detachment.
George D. Yancopoulos, M.D., Ph.D., Regeneron’s co-founder and Chief Scientific Officer, said the approvals reinforce EYLEA HD’s role as a preferred option for retinal specialists. He noted that EYLEA HD is the first treatment for RVO capable of potentially reducing injection frequency by half compared to existing therapies, an advancement that may significantly ease the treatment burden for patients.
EYLEA HD is now approved with dosing ranges of every 8 to 16 weeks for wAMD and DME after three initial monthly doses, every 8 to 12 weeks for DR, and every 8 weeks for RVO after three to five initial monthly injections. However, Regeneron cautioned that some patients in clinical trials did not maintain stable responses at longer intervals and may need to return to monthly dosing.
Regeneron also provided updates on its pre-filled syringe (PFS) program. The company continues to work with Catalent Indiana, LLC, part of Novo Nordisk, to address issues identified during an FDA site inspection in July 2025. Additionally, Regeneron plans to submit an application by January 2026 to add an alternative PFS manufacturing filler to the EYLEA HD biologics license.
To support patient access, the company highlighted its EYLEA 4U program, which helps patients navigate insurance coverage and offers financial assistance for eligible individuals. With expanded dosing options and supportive infrastructure, Regeneron aims to enhance treatment flexibility and accessibility for people living with serious retinal diseases.