March 25, 2015
"Diabetes is a serious public health crisis, affecting more patients every year," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Today's approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication." In appropriate patients, aflibercept is injected into the eye every month for 5 months and then every 2 months as needed, the FDA said. The safety and efficacy of aflibercept to treat diabetic retinopathy in patients with DME were demonstrated in two clinical studies involving a total of 679 patients randomly assigned to receive aflibercept or macular laser photocoagulation (control group). At week 100, those treated with aflibercept showed significant improvement in the severity of their diabetic retinopathy compared with control patients, the FDA said. The most common ocular side effects associated with aflibercept include conjunctival hemorrhage, eye pain, cataracts, vitreous detachment, and increased intraocular pressure. Serious adverse reactions include endophthalmitis and retinal detachment. Aflibercept had breakthrough therapy designation from the FDA for treatment of diabetic retinopathy with diabetic macular edema. Aflibercept is already approved in the US to treat wet (neovascular) age-related macular degeneration and diabetic macular edema and macular edema secondary to retinal vein occlusions. Last month, the FDA approved ranibizumab injection (Lucentis, Genentech) 0.3 mg to treat diabetic retinopathy in patients with diabetic macular edema.