Regeneron’s Eye Injection Eylea Gets New Indication

Regeneron Pharmaceuticals’ eye injection Eylea received an expanded indication from the FDA to cover macular edema following branch retinal vein occlusion.

The agency’s decision last week was based on results of a double-masked, randomized Phase III study of 181 patients that compared 2 mg of Eylea (aflibercept) every four weeks to macular laser photocoagulation. By 24 weeks, far more patients given Eylea had gained a 17-letter mean improvement over baseline, compared with just 6.9 letters in the control group, Regeneron said.

The drugmaker said it still has applications pending for the new indication in several global regions, including the European Union and Japan.

The new indication is the latest in a string of new indications the drug has garnered since originally winning FDA approval in 2011 to treat wet age-related macular degeneration. In 2012, the drug won an indication to treat macular degeneration after central retinal vein occlusion. In August, Eylea won EU clearance to treat diabetic macular edema, with a breakthrough therapy designation for the same indication following in the U.S. in September. That same month, the drug won Japanese approval for myopic choroidal neovascularization.

Eylea generated roughly $1.4 billion in U.S. sales last year, a 68-percent increase over the previous year, and $472 million elsewhere in 2013, according to the company. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.