Eylea HD injection 8mg sBLA accepted for FDA Priority Review

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN).

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA target action date is August 19, 2025, following the use of a Priority Review voucher.

The sBLA is supported by data from across the Eylea HD clinical program, including the Phase III QUASAR trial investigating Eylea HD in RVO. As previously presented, 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 receiving Eylea Injection 2mg dosed every 4 weeks. Currently, all anti-VEGF therapies approved to treat RVO, including Eylea, are indicated for monthly dosing.