Swiss drug maker Roche Holding AG said Monday that the U.S. Food and Drug Administration has approved Lucentis for the treatment of diabetic retinopathy in people with diabetic macular edema.
The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from two Phase III clinical trials.
Diabetic retinopathy with diabetic macular edema is a common diabetic eye disease and a leading cause of blindness in American adults under 55. Diabetic macular edema impacts nearly 750,000 Americans, about 10% of people with diabetic retinopathy, which is caused by elevated blood sugar levels damaging the fine blood vessels of the retina.
This is the fourth indication for which Lucentis is approved by the FDA for treatment of serious eye diseases. It was approved for the treatment of wet age-related macular degeneration in 2006, macular edema following retinal vein occlusion in 2010 and diabetic macular edema in 2012.
Lucentis has been studied in 21 clinical trials worldwide in more than 9,080 patients.
Lucentis was developed by Roche subsidiary Genentech, which retains commercial rights in the U.S. Novartis AG (NVS) has exclusive commercial rights for the rest of the world.
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