FDA Approves New Treatment for Diabetic Retinopathy

Meghan Ross, Associate Editor

The FDA has approved a new treatment for 1 of the most common diabetic eye diseases.

The FDA has approved a new treatment for 1 of the most common diabetic eye diseases.

The administration today expanded the approved use for aflibercept (Eylea) injection to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).

Eylea was already approved to treat wet age-related macular degeneration and to treat DME and macular edema secondary to retinal vein occlusions.

Eylea’s safety and efficacy was tested in 679 patients in 2 clinical studies where subjects received either Eylea or macular laser photocoagulation. At week 100, the patients who were administered Eylea saw significant improvement in the severity of their DR when compared to the patients who underwent macular laser photocoagulation.

The treatment is injected into the eye once a month for the first 5 injections, and then it is injected once every 2 months. Patients should also be working to control their blood sugar, blood pressure, and cholesterol, alongside the treatment, the FDA stated.

Side effects of Eylea include bleeding of the conjunctiva, eye pain, cataracts, floaters, and increased pressure inside the eye.

The FDA noted that DR is a leading cause of blinding in US adults.

“Today’s approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The FDA also recently approved ranibizumab injection (Lucentis) 0.3 mg to treat DR in patients with DME.