Highlights  

  • FDA approves Regeneron’s EYLEA HD for retinal vein occlusion. 
  • Monthly dosing option added across all previously approved indications. 
  • EYLEA HD allows eight-week dosing after initial monthly treatment, reducing injections. 
  • Phase 3 QUASAR trial shows non-inferior visual gains versus EYLEA every four weeks. 
  • U.S. net sales for EYLEA HD rose 10% year-over-year to USD 431 million in Q3 2025. 

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the U.S.Food and Drug Administrationhas approved EYLEA HD (aflibercept injection 8 mg) for adult patients with macular edema following retinal vein occlusion. This approval adds a monthly (every four-week) dosing option across all previously approved indications, including wet age-related macular degeneration (wAMD), diabetic macular edema, and diabetic retinopathy. 

EYLEA HD also introduces a dosing schedule every eight weeks after an initial monthly period, marking the first FDA-approved RVO treatment with this extended dosing interval. This schedule can potentially reduce the total number of injections required, offering greater convenience to patients and flexibility for physicians in tailoring individualized treatment plans.

Clinical Trial Data Supports Approval

The FDA approval is supported by results from the Phase 3 QUASAR trial, conducted by Bayer under collaboration with Regeneron. At 36 weeks, patients receiving EYLEA HD every eight weeks demonstrated non-inferior visual acuity gains compared to those treated with EYLEA every four weeks. 

The results were consistent across branch, central, and hemiretinal vein occlusions. The most common adverse reactions reported in ≥3% of patients included increased intraocular pressure, blurred vision, cataract, conjunctival hemorrhage, ocular discomfort, and vitreous detachment. 

Despite a recent setback with the supplemental BLA for the pre-filled syringe formulation, Regeneron plans a new submission in January 2026 using an alternate manufacturing filler.

Sales Performance

EYLEA HD’s U.S. net sales reached USD 431 million in Q3 2025, up 10% from USD 392 million in the same period last year. However, combined U.S. net sales for EYLEA HD and EYLEA fell 28% to USD 1.11 billion, reflecting competitive pressures and patient transitions to EYLEA HD. 

The expanded dosing flexibility and approval for RVO are expected to enhance EYLEA HD’s competitive position, potentially supporting broader adoption and improving patient adherence to therapy. 

Conclusion 

Regeneron’s FDA approval of EYLEA HD for RVO and monthly dosing across indications marks a key milestone in retinal care. Supported by the QUASAR trial, the drug offers patients and physicians greater flexibility while reducing the treatment burden. As Regeneron addresses manufacturing and competitive challenges, EYLEA HD is poised to strengthen its market presence and drive growth in the retinal disease segment. 

Regeneron Pharmaceuticals’ shares closed at USD 702.75 on November 19, marking a 0.13% increase from the prior session.

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