FDA Expands Usage of Regeneron’s Eylea

Regeneron has received FDA approval of Eylea (afilbercept) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The approval came on March 25, approximately six months after FDA granted the drug Breakthrough Therapy Designation status for this indication. This approval marks the fourth FDA indication for Eylea, which was previously approved for macular edema following central retinal vein occlusion, wet-aged macular degeneration, and diabetic macular edema. The recommended dosage of Eylea for the treatment of diabetic retinopathy in patients with DME is two milligrams every eight weeks after five initial monthly injections, however it may be dosed as frequently as two milligrams every four weeks (additional efficacy for this frequency was not determined).

"Diabetic retinopathy coupled with DME is a serious complication of diabetes that can threaten the vision of many working-age adults. In addition to improving visual acuity in people with DME, Eylea also improves these patients' retinal vessel damage, or retinopathy. Eylea is the only treatment option for diabetic retinopathy in patients with DME that is approved for less than monthly dosing after an initial monthly dosing period,” said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, in a press release.

In February 2015, FDA granted Genentech approval of Lucentis (ranibizumab injection 0.3 mg) for the treatment of diabetic retinopathy in patients with DME. Lucentis was approved for the treatment of wet age-related macular degeneration in 2006, DME in 2012, and has been used to treat macular edema following retinal vein occlusion since 2010. 

Source: Regeneron Pharmaceuticals