The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.
Diabetic retinopathy (DR) is the most common diabetic eye disease and is a leading cause of blindness in working adults in the United States.
“Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication.”
In February, the FDA approved Lucentis (ranibizumab) injection 0.3 mg to treat DR in patients with DME.
Eylea is administered by a physician as an injection into the eye. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol.
The safety and efficacy of Eylea to treat DR in patients with DME were evaluated in 679 participants in two clinical studies where participants were randomly assigned to receive Eylea or macular laser photocoagulation, a laser-based treatment used to burn small areas of the retina. At week 100, participants being treated with Eylea showed significant improvement in the severity of their DR, compared to patients who did not receive Eylea.
Aflibercept is an anti-VEGF drug that has also been FDA approved for wet age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion– all vision-threatening conditions.