Regeneron's EYLEA HD Gains FDA Clearance for Branch Retinal Vein Occlusion With Macular Edema, Expands Flexible Dosing Options

Regeneron Pharmaceuticals has secured FDA approval for EYLEA HD (aflibercept injection 8 mg) in treating macular edema secondary to retinal vein occlusion, marking a significant advancement in ophthalmologic care. The authorization simultaneously introduces monthly dosing schedules across all current therapeutic applications, encompassing wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and retinal vein occlusion.

Disease Burden and Clinical Need

Retinal vein occlusion represents a substantial public health concern, affecting over 28 million individuals worldwide. As one of the predominant retinal vascular pathologies, RVO frequently results in vision loss and requires ongoing management. The condition manifests across multiple presentations, including branch, central, and hemiretinal variants. Traditional therapeutic approaches typically necessitate frequent intraocular injections, placing considerable burden on patients and healthcare systems alike.

EYLEA HD: A Step Forward in Treatment Paradigm

The newly approved EYLEA HD distinguishes itself as the inaugural FDA-cleared therapeutic option enabling extended dosing intervals for RVO management. Following an initial monthly treatment phase, patients can transition to eight-weekly administration, potentially decreasing the cumulative injection frequency. Concurrently, the FDA authorization encompasses a monthly (every four-week) dosing alternative, providing clinicians with enhanced flexibility to customize therapeutic schedules based on individual patient characteristics and disease trajectory.

Evidence Supporting Approval

The approval derives from Phase 3 QUASAR trial findings, which directly compared EYLEA HD against EYLEA (aflibercept injection 2 mg) in the RVO population. At the 36-week assessment point, EYLEA HD administered every eight weeks demonstrated non-inferior visual acuity improvements relative to conventional EYLEA dosing every four weeks. Notably, this efficacy consistency extended across branch, central, and hemiretinal occlusion subtypes, suggesting broad applicability across RVO presentations.

Commonly documented adverse events (≥3%) with EYLEA HD encompassed elevated intraocular pressure, visual blurring, cataracts, conjunctival hemorrhage, ocular discomfort, and vitreous detachment—a safety profile consistent with the aflibercept class.

Market Performance and Future Outlook

EYLEA HD achieved U.S. net sales of $431 million in the third quarter of 2025, reflecting a 10% year-over-year increase. However, aggregate U.S. revenues for combined EYLEA HD and EYLEA formulations decreased 28% to $1.11 billion, indicating shifting patient populations toward the higher-concentration formulation amid competitive market dynamics. The company anticipates a supplemental biologics license application resubmission in January 2026, addressing previous manufacturing facility inspection findings to advance pre-filled syringe formulation options.