FDA Expands Indication for Aflibercept to Treat Diabetic Retinopathy

On March 25, 2015, the FDA approved an expanded indication for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema. The injection is administered by a physician once per month for the first five injections and then once every 2 months. It is intended to be prescribed along with appropriate interventions to control blood glucose, blood pressure, and cholesterol.

The safety and efficacy of the expanded indication were demonstrated in two clinical trials involving 679 patients with diabetic retinopathy and diabetic macular edema. The participants received either aflibercept or macular laser photocoagulation. At week 100, participants who were treated with aflibercept showed significant improvement in the severity of their diabetic retinopathy, compared with participants in the other group.

The most common adverse effects include bleeding of the conjunctiva, eye pain, cataracts, floaters, increased intraocular pressure, and vitreous detachment. Other adverse effects may include endophthalmitis and retinal detachment. Eylea was approved by the FDA to treat wet age-related macular degeneration in November 2011 and diabetic macular edema in July 2014. The product is made by Regeneron Pharmaceuticals, Inc. More information can be found at regeneron.com/eylea.