FDA approves Genentech's Lucentis for diabetic macular edema

SILVER SPRING, Md. — Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

The Food and Drug Administration approved Lucentis (ranibizumab) for diabetic macular edema, a cause of vision loss in people with diabetes. The drug already was approved for age-related macular degeneration.

"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," FDA Division of Transplant and Ophthalmology Products director Renata Albrecht said. "Today's approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."

According to the Centers for Disease Control and Prevention, Type 1 and Type 2 diabetes affect about 26 million people in the United States and are the leading cause of blindness among people ages 20 to 74 years. In 2010, 3.9 million adult diabetics reported vision problems. DME happens when fluid leaks into the macula, the central part of the retina where sharp, straightforward vision occurs.


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