Regeneron's Eylea gains FDA approval for DME

The Food and Drug Administration has approved US biotech firm Regeneron Pharmaceuticals’ (Nasdaq: REGN) Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME).

The recommended dosage of Eylea in patients with DME is 2mg every two months (eight weeks) after five initial monthly injections. Although Eylea may be dosed as frequently as 2mg every four weeks, additional efficacy was not demonstrated when the drug was dosed every four weeks compared to every eight weeks.

Eylea is already available in the USA for the treatment of neovascular age-related macular degeneration and macular edema following central retinal vein occlusion, following 2011 and 2012 approvals. Regeneron maintains exclusive rights to Eylea in the USA, but Germany’s Bayer (BAYN: DE) has licensed the exclusive marketing rights outside the USA , where the companies share equally the profits from sales, except for Japan, where Regeneron receives a percentage of net sales.