February 06, 2015
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FDA approves Lucentis for diabetic retinopathy in patients with diabetic macular edema

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The FDA today announced the expanded approval of Lucentis 0.3 mg for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a news release from the agency.

Administered by a physician as an injection into the eye once a month, Lucentis (ranibizumab, Genentech) should be used alongside appropriate treatments to manage blood pressure, blood sugar and cholesterol.

“Diabetes is a serious public health crisis, affecting more patients every year,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”

Lucentis was previously approved to treat diabetic macular edema secondary to retinal vein occlusions and neovascular age-related macular degeneration. The FDA granted breakthrough therapy designation to Lucentis for diabetic retinopathy with diabetic macular edema after reviewing the new use under the agency’s expedited priority program.