Regeneron Secures FDA Approval For EYLEA HD In RVO With Extended Dosing Backed By QUASAR Trial Data

Regeneron Pharmaceuticals has received U.S. FDA approval for EYLEA HD® (aflibercept 8 mg) Injection for treating macular edema following retinal vein occlusion (RVO). The approval allows dosing every eight weeks after an initial monthly regimen. The FDA has also cleared a monthly (4-week) dosing option across all approved indications, wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and RVO, for patients who may require a return to more frequent treatment.

"We believe 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,” said George D. Yancopoulos, M.D., Ph.D., co-founder, Board Co-Chair, President and Chief Scientific Officer, at Regeneron. “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.”

The decision for RVO is supported by results from the Phase 3 QUASAR trial, which demonstrated that EYLEA HD dosed every eight weeks delivered non-inferior visual acuity gains compared to the 2 mg EYLEA dosed every four weeks. These positive results were observed across all RVO subtypes. Common adverse events (≥3%) included elevated intraocular pressure, blurred vision, cataract, conjunctival hemorrhage, eye pain or irritation, and vitreous detachment.

Regeneron also provided an update on its EYLEA HD pre-filled syringe, noting ongoing collaboration with Catalent Indiana to resolve issues identified in a July 2025 FDA inspection. The company plans to submit an application for an alternate manufacturing filler by January 2026. EYLEA HD remains approved with flexible extended dosing intervals depending on the indication. Regeneron continues to support patient access through its EYLEA 4U program, which offers guidance on insurance coverage and financial assistance options.