FDA Approves Eylea to Treat Diabetic Retinopathy in Patients With Diabetic Macular Edema

The FDA today approved the use of Eylea (afilbercept) injections to treat diabetic retinopathy in patients who have diabetic macular edema (DR), the most common diabetic eye disease and a leading cause of blindness in adults.

According to CDC, this disease affects more than 33% of adults with diabetes age 40 and older had some form of DR; with 29 million Americans suffering either type 1 or type 2 diabetes, the potential for DR is significant in the US population.

Eylea, made by Regeneron, is administered through monthly injections for 5 months, then every 2 months. It is intended to be used alongside a modified diet and other interventions to control blood sugar, blood pressure, and cholesterol.

Safety and efficacy of Eylea to treat DR patients with DME evaluated in 2 clinical trials involving 679 patients. They were randomly assigned to have Eylea or macular laser photocoagulation, a laser treatment that burns small areas of the retina. At week 100, patients with Eylea showed significant improvement over those with the laser treatments.

Common side effects were bleeding of the conjunctiva, eye pain, cataracts, floaters, increased eye pressure, and separation of the interior jelly of the eye from the retina. Serious event included retinal detachments and infections within the eye.