February 7, 2015

FDA approves Lucentis to treat diabetic retinopathy in patients with diabetic macular edema

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FDA approves Lucentis to treat diabetic retinopathy in patients with diabetic macular edema

The U.S. Food and Drug Administration announced today that they have expanded the approved use for Lucentis 0.3 mg (Genentech) to treat diabetic retinopathy in patients with diabetic macular edema. The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula resulting in blurred vision. Lucentis also is approved to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula.
Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. “Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”
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