FDA Approves 'Breakthrough Therapy' for Diabetic Retinopathy
Diabetic retinopathy is the most common eye disease associated with diabetes and is currently the leading cause of blindness in the U.S., the FDA reports.
Last Wednesday, the FDA approved the use of Eylea to treat diabetic retinopathy. Eylea is a once-monthly, physician-administered injection for the first five treatments, after which patients can receive the injections once every two months, a press release on the announcement reported.
“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. “[This] approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication.”
'Breakthrough therapy' designation
The FDA designated the drug as a breakthrough therapy, a classification that can be granted if a drug demonstrates significant potential to immediately treat serious or life-threatening conditions.
Trials to test the safety and efficacy of the drug included 679 participants in two clinical studies. After 100 weeks, patients who had been given Eylea showed "significant improvement" in diabetic retinopathy symptoms compared with individuals who did not receive the drug.