FDA Approves Drug to Treat Diabetic Retinopathy
On Wednesday, the U.S. Food and Drug Administration (FDA) approved aflibercept (Eylea) to treat diabetic retinopathy in patients suffering from macular edema.
The approval is based on the results of two clinical studies involving more than 650 patients. Patients received either laser photocoagulation or aflibercept. At about two years, according to the FDA’s statement, patients on aflibercept showed significant improvement vs. those who did not receive the drug.
For the first five months, administration of aflibercept is via a monthly injection by a physician. Afterwards, it is injected into the eye by a physician every two months.
Regeneron Pharmaceuticals’ aflibercept is already approved to treat wet age-related macular degeneration, diabetic macular edema, and macular edemas secondary to retinal vein occlusions.
Retinal detachments and endophthalmitis can occur. Common side effects include: eye pain; cataracts; bleeding of the conjunctiva; floaters; increased pressure inside the eye; and separation of the interior jelly of the eye from the retina.
“Today’s approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Roche’s ranibizumab injection (Lucentis), which has won the same approvals, received FDA approval to treat this condition in February.
--Stephanie Vaccaro
Reference:
1. U.S. Food and Drug Administration. FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema [press release]. www.fda.gov. 2015 Mar 25.
