(By Balachander) U.S. health regulators have cleared Roche's Lucentis injection for the treatment of a type of diabetic eye disease.
The U.S. Food & Drug Administration (FDA) approved Lucentis to treat diabetic macular edema (DME), a condition that can cause blindness in people with diabetes.
The FDA previously had okayed Lucentis to treat wet age-related macular degeneration (AMD), and for treating macular edema following retinal vein occlusion.
According to the FDA, the approval of Lucentis in DME was based on two three-year clinical studies that showed improved clinical outcomes. Results demonstrated that between 34 percent and 45 percent of those treated with monthly Lucentis 0.3 mg gained at least three lines of vision compared with 12 percent to 18 percent of those who did not receive an injection.
Side effects include bleeding under the lining of the eye and increased eye pressure.
According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects about 26 million people in the United States 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.
Shipments of Lucentis 0.3 mg is expected to begin August 15.
Lucentis is being developed by Roche's Genentech unit and Novartis (NYSE:NVS) for eye disorders. Genentech retains commercial rights in the U.S. and Novartis holds commercial rights outside the U.S.