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

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

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 ...

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 ...

There are two main types of RVO: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein and in BRVO ...

There are two main types of RVO: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein and in BRVO ...

In the European Union and United Kingdom, aflibercept 8 mg (Eylea HD in the US) is currently approved for neovascular ...

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

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

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today a settlement and license agreement with ...