Bayer has taken another step toward fulfilling blockbuster ambitions for its eye drug Eylea. The German drugmaker asked European regulators to approve the vision-loss treatment for patients with diabetic macular edema (DME). With diabetes on the rise all over the world, the new indication could offer long-term growth for the already fast-rising drug.
Developed with U.S.-based Regeneron ($REGN), Eylea is approved in Europe for patients with age-related macular degeneration and for patients with vision loss stemming from central retinal vein occlusion (CRVO). Since Bayer launched it in the EU last year, the drug has grown to €122 million ($162.6 million) in first-half 2013 sales.
With the drug romping through the U.S. market--$643.7 million in first-half sales--Bayer expects Eylea to deliver €1 billion-plus in annual sales. New indications will be key to achieving that goal. The CRVO use will help, but approval for patients with DME is a bigger prize. The companies are also developing Eylea for patients with macular edema following a branch retinal vein occlusion (BRVO); they unveiled positive data for that use in late October.
In Europe, Eylea faces competition from Novartis ($NVS), which sells the Roche ($RHHBY) drug Lucentis there. Lucentis has been a solid performer for both Swiss drugmakers, and as the first to market, Lucentis has already racked up approvals in DME and BRVO. Plus, in July, Lucentis nabbed its fourth EU indication, for patients with vision problems caused by choroidal neovascularization secondary to pathologic myopia (myopic CNV).
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