The FDA approved a second drug to treat diabetic retinopathy in patients with diabetic macular edema.
The US Food and Drug Administration (FDA) approved a new use for aflibercept (Eylea/Regeneron). The FDA ruled today that the drug may be used to treat diabetic retinopathy in patients with diabetic macular edema (DME). The drug is already in use for treating age-related wet macular degeneration.
It is the second drug approved this year to treat DME. In February, the FDA approved ranibizumab (Lucentis/Genentech) for that use.
Aflibercept is administered by an injection into the eye once a month for the first 5 injections, then once every 2 months.
It should be used in addition to standard diabetes treatments aimed at controlling blood sugar, blood pressure and cholesterol levels. Diabetic Retinopathy can cause blindness.
The safety and efficacy of the drug was evaluated in 679 participants in 2 clinical studies where subjects were randomized either to Eylea of macular laser photocoagulation with lasers.
At week 100, the patients treated with Eylea showed “significant improvement in the severity of the diabetic retinopathy,” compared to the group that got laser treatment the FDA said in announcing the approval.
Common side effects were bleeding of the conjunctiva, eye pain, cataracts, floaters, increased pressure inside the eye, and vitreous detachment.
The FDA approved the drug under a breakthrough therapy protocol.