Eylea Earns FDA Approval To Treat Diabetic Macular Edema

The U.S. Food and Drug Administration has approved the eye drug Eylea for the treatment of diabetic macular edema, according to the drug makers Regeneron Pharmaceuticals, Inc.

Diabetic macular edema (DME) is a common complication for those with diabetes. Of the 29.1 million Americans with diabetes, 1.5 million have been diagnosed with DME. This occurs when the blood vessels of the retina are damaged due to the chronic high blood sugar levels associated with diabetes. It causes swelling of the macula, the center of the retina that controls central, fine vision, and can lead to severe vision loss or blindness. 

“Diabetic macular edema is a leading cause of vision loss among working-age adults in the U.S., and we are pleased to be able to offer a new treatment option to these patients,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer and President of Regeneron.

The injectable medication, originally prescribed to treat wet macular degeneration ( a disease of the eye that results in a loss of vision at the center of the field of vision when blood vessels abnormally leak fluid into the macula ) was approved for expanded use in late July.

The drug is designed to inhibit vascular endothelial growth factor (VEGF), a protein that encourages blood vessel leakage and the growth of new blood vessels.

Eylea was tested for one year as part of Phase 3 studies and proved to help improve the eyesight of those receiving bi-monthly doses after five initial monthly doses, allowing them to read two more lines of an eye chart than those in a control group.

“Our clinical studies have demonstrated that treatment with Eylea can help improve and maintain vision with every eight-week week dosing after five initial monthly doses,” Yancopoulos said. “Eylea is the first VEGF inhibitor approved for dosing on a less than monthly basis for the treatment of DME.”

Eylea was originally launched in 2011.