Updated on 23 September 2014
The German drug multinational said that the approval is based on positive data from the Phase III MYRROR study in myopic CNV
Singapore: Bayer's Eylea (aflibercept) injection for myopic choroidal neovascularization (myopic CNV) has received an approval from Japan's Ministry of Health, Labor and Welfare (MHLW).
Bayer's Japanese healthcare subsidiary, Bayer Yakuhin said that Eylea that has been licensed from the US biotech firm Regeneron Pharmaceuticals, has already been approved in Japan for the treatment of patients with neovascular age-related macular degeneration and macular edema secondary to central retinal vein occlusion (CRVO).
The company further added in a statement that 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).
The German drug multinational said that the approval is based on positive data from the Phase III MYRROR study in myopic CNV. Bayer recorded Eylea sales of $316.4 million (194 million euros) in the second quarter of 2014.