Bayer’s Eylea approved in Japan for myopic CNV

22 September 2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer (BAYN: DE) has received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Eylea (aflibercept) Injection for myopic choroidal neovascularization (myopic CNV).

Eylea, licensed from US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN), has already been approved in Japan for the treatment of patients with neovascular age-related macular degeneration (wet AMD), and macular edema secondary to central retinal vein occlusion (CRVO). Marketing authorization applications have been submitted in Japan for the treatment of diabetic macular edema (DME) and macular edema secondary to branch retinal vein occlusion (BRVO).

Bayer stated that the approval is based on positive data from the Phase III MYRROR study in myopic CNV. Bayer recorded Eylea sales of 194 million euros ($316.4 million) in the second quarter of 2014.

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