Eylea receives FDA approval for DME treatment

August 5, 2014

The U.S. Food and Drug Administration (FDA) approved Eylea (aflibercept, Regeneron) injection for the treatment of diabetic macular edema (DME).

Tarrytown, NJ-The U.S. Food and Drug Administration (FDA) approved Eylea (aflibercept, Regeneron) injection for the treatment of diabetic macular edema (DME).  

The recommended dosage of Eylea in patients with DME is 2 milligrams (mg) every two months after five initial monthly injections. Although Eylea may be dosed as frequently as 2 mg every four weeks, additional efficacy was not demonstrated when Eylea was dosed every four weeks compared to every eight weeks, according to Regeneron Pharmaceuticals. Eylea is available as a single, 2-mg strength intravitreal injection for all approved indications.

Europe approves Eylea for DME

The drug was approved in the U.S. for the treatment of wet age-related macular degeneration (AMD) in 2011, and for the treatment of macular edema following central retinal vein occlusion (CRVO) in 2012. Eylea has also been approved in the European Union and other countries for use in wet AMD and macular edema following CRVO.

Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, it has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and EU for Eylea for the treatment of macular edema following branch retinal vein occlusion (BRVO).

FDA approves Ozurdex for use in some DME patients

Related Content:

News