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Regeneron also noted its plans to submit an application to include an alternate PFS manufacturing filler for the EYLEA HD BLA to the FDA by January 2026. References: EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications.. The FDA approval for the treatment of RVO is based on data from the Phase 3 QUASAR trial that evaluated the efficacy and safety of EYLEA HD compared to EYLEA ® (aflibercept) Injection 2 mg in patients with RVO. QUASAR met its primary endpoint at 36 weeks, with EYLEA HD patients dosed every 8 weeks (after either 3 or 5 monthly doses) achieving non-inferior visual acuity gains compared to those.

In the EYLEA HD groups, patients could be treated as frequently as every 8 weeks based on protocol-defined visual and anatomic criteria, starting at week 16. Patients ranged from 50 to 96 years of age with a mean of 74.5 years.. On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA HD (aflibercept). The supplemental application is for the addition of extended dosing intervals (up to every 24 weeks) of EYLEA HD injection 8 mg across all approved indications. The FDA.