EMA Panel Recommends EU Approval of Bayer's Aflibercept 8 mg for Retinal Vein Occlusion

Reuters12-12

EMA Panel Recommends EU Approval of Bayer's Aflibercept 8 mg for Retinal Vein Occlusion

The Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency $(EMA)$ has recommended Bayer AG's aflibercept 8 mg (114.3 mg/ml solution for injection) for marketing authorization in the European Union for the treatment of visual impairment due to macular edema following retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion. This would be the third indication for Eylea 8 mg in the EU. Aflibercept 8 mg, known as Eylea HD in the United States, is being jointly developed by Bayer and Regeneron. The European Commission's final decision is expected in the coming weeks.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bayer AG published the original content used to generate this news brief on December 12, 2025, and is solely responsible for the information contained therein.

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