FDA OKs New Rx for Diabetic Eye Disease

Regeneron announces FDA approval of Eylea to treat diabetic macular edema

(RxWiki News) The FDA has given a thumbs up to a new medication to treat an eye disease that affects hundreds of thousands of people with diabetes.

According to drug maker Regeneron, the FDA has approved Eylea (aflibercept) to treat diabetic macular edema (DME).

DME is a complication of diabetes that happens when blood vessels in the retina leak into the macula, the part of the eye responsible for central vision.

"See an eye doctor regularly if you have diabetes."

Eylea is a vascular endothelial growth factor (VEGF) inhibitor made as an injection for the eye. The medication is meant to block the growth of new blood vessels and reduce the ability of fluid to pass through blood vessels into the eye.

The FDA approved Eylea injections at a dosage of 2 milligrams every eight weeks after starting with five monthly injections.

The approval and dosage was determined through data from phase III research on 862 patients. Researchers compared results in patients who received 2 milligrams of Eylea each month, 2 milligrams of Eylea every two months or macular laser photocoagulation (procedure to form scar tissue and seal blood vessels).

According to a Regeneron press release, patients who received either dose of Eylea had greater improvements in best corrected visual acuity (BCVA) than those who received laser photocoagulation. BCVA is a measure of vision.

The most common eye-related side effects reported in the trials were conjunctival hemorrhage (a red patch appearing in the white of the eye) eye pain, cataracts (clouding of the lens of the eye) and floaters (spots in vision). Other side effects of Eylea included high blood pressure and blood clots.

Regeneron has yet to provide pricing information.

Review Date: 
July 31, 2014