Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion and broadening ...

active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

EYLEA HD is a treatment for retinal vein occlusion (RVO) that allows for dosing every 8 weeks after initial monthly doses, potentially halving injections. What is the FDA's action date for EYLEA ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

for Eylea HD (aflibercept) injection 8mg for priority review. The application aims to extend the therapy’s use for treating macular oedema after retinal vein occlusion (RVO) and to widen the ...

Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...