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FDA Approves Lucentis (Ranibizumab Injection) for Diabetic Macular Edema
On August 10, the FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.
Lucentis is administered as a monthly injection by a healthcare professional. The drug 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 about 26 million people in the U.S. and is the leading cause of new blindness among people aged 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.
The safety and effectiveness of Lucentis in the treatment of DME were established in two clinical studies involving a total of 759 patients who were treated and followed for 3 years. The patients were randomly assigned to receive monthly injections of Lucentis 0.3 mg or 0.5 mg, or no injections, during the first 24 months of the studies. After 24 months, all patients received monthly Lucentis 0.3 mg or 0.5 mg.
The studies measured the number of patients who gained vision, as measured on an eye chart. Between 34% and 45% of those treated with monthly Lucentis 0.3 mg gained at least three lines of vision, compared with 12% to 18% of those who did not receive an injection. No additional benefit was observed with the higher monthly Lucentis dose of 0.5 mg.
The FDA previously approved Lucentis to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula. Lucentis also is approved to treat macular edema following retinal vein occlusion (a blockage of the small veins that carry blood away from the retina that can cause fluid to leak into the macula).
Lucentis is marketed by Genentech.
For more information, visit the FDA Web site.