EU Approves Bayer's Eylea 8 Mg For Extended 6-Month Dosing In Retinal Diseases

(RTTNews) - Bayer (BAYZF.PK, BAYRY.PK, BYR.L), a German pharmaceutical and life sciences major, announced that the European Commission has granted a label extension in the European Union for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME.

Eylea 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing, Bayer said.

Eylea 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.

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