Aflibercept approved for diabetic retinopathy in diabetic macular edema

Aflibercept (Eylea) has received expanded approval to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME), the FDA recently announced.

It is administered as an injection into the eye once a month for the first 5 injections and then once every 2 months. Aflibercept was previously approved to treat wet age-related macular degeneration and DME and macular edema secondary to retinal vein occlusions, according to an FDA press release.

Safety and efficacy of the new indication were based on 2 trials with 679 participants in which patients on the drug showed significant improvement in the severity of their DR, compared to patients who did not receive it. The most common side effects are bleeding of the conjunctiva, eye pain, cataracts, floaters, increased intraocular pressure, and vitreous detachment. Serious adverse reactions include endophthalmitis and retinal detachments.