DME is a sight-threatening eye disease that occurs in people with diabetes. Lucentis is intended to be injected once a month by a healthcare professional and used along with good diabetic blood sugar control.
“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing DME,” said Renata Albrecht, MD, director of the division of transplant and ophthalmology products in FDA’s Center for Drug Evaluation and Research, in the release. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”
FDA previously approved Lucentis to treat wet (neovascular) age-related macular degeneration. Lucentis also is approved to treat macular edema following retinal vein occlusion.
Lucentis is marketed by South San Francisco-based Genentech.
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