FDA clears first drug for diabetic macular edema

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The FDA approved ranibizumab injection (Lucentis, Genentech, which is a subsidiary of the Roche Group) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

An injection administered once a month by a healthcare professional, ranibizumab is intended to be used along with good diabetic blood sugar control.

DME is a condition in which fluid leaks into the macula, the center part of the retina where sharp, straight-forward vision occurs. The fluid makes the macula swell, causing vision to blur.

According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects approximately 26 million people in the U.S., and is the leading cause of new blindness among people ages 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.

To date, the standard of care in the U.S. for DME has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision (Arch Ophthalmol 1985;103:1796-806).

Ranibizumab, in the dose of 0.5 mg once monthly, was first approved by the FDA for treatment of wet age-related macular degeneration in 2006 and for macular edema following retinal vein occlusion in 2010. With this approval, ranibizumab 0.3 mg was cleared for DME, and physicians can order it immediately with shipments expected to begin Aug. 15, San Francisco-based Genentech said in its press release.

“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” said Renata Albrecht, MD, director of the division of transplant and ophthalmology products in FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”