By Fineline Cube 
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGNN) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg for priority review. The application seeks approval for Eylea HD’s use in macular edema following retinal vein occlusion (RVO) and proposes expanding the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA is expected to announce its decision by August 19, 2025.
Clinical Trial Support
The sBLA is supported by data from the Eylea HD clinical program, including the Phase III QUASAR trial. In the trial, patients with RVO receiving Eylea HD 8 mg dosed every 8 weeks (after 3 or 5 monthly doses) demonstrated non-inferiority in visual acuity gains compared to those receiving Eylea 2 mg dosed every 4 weeks. Currently, all approved anti-VEGF therapies for RVO require monthly dosing.
Market Implications
If approved, Eylea HD could offer patients and healthcare providers greater flexibility in treatment scheduling. The ability to extend dosing intervals while maintaining efficacy represents a significant advancement in the management of RVO-related macular edema.-Fineline Info & Tech