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 for ...

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

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 ...

Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics ...

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

Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.

Bayer seeks EMA approval for aflibercept 8 mg for treatment of retinal vein occlusion: Berlin Thursday, April 10, 2025, 16:00 Hrs [IST] Bayer has submitted an application to the E ...

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...