EU approval of new Eylea indication

German pharma major Bayer (BAYN: DE) has received European approval for Eylea (aflibercept) Injection for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV).

In the European Union, Eylea, developed with US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN), is already approved for the treatment of patients with neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). In Japan, Eylea is approved for the treatment of visual impairment due to myopic choroidal neovascularization, (wet) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO) and diabetic macular edema.

Regeneron maintains exclusive rights to Eylea in the USA. Bayer HealthCare licensed the exclusive marketing rights outside the USA, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales. Eylea generated sale of 320 million euros ($354 million) for Bayer in the third quarter of this year.