Posted by Michael Wonder on 18 Apr 2017
FDA approves Genentech’s Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States
17 April 2017 - Granted priority review designation by the FDA based on analysis of results from a National Institutes of Health funded collaborative group study.
Genentech today announced that the U.S. FDA approved Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 741 and affects nearly 7.7 million people in the U.S.
With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular oedema, a complication of diabetic retinopathy that causes swelling in the back of the eye.
In February 2015, Lucentis received FDA approval for the treatment of diabetic retinopathy in people with DME based on data from the pivotal RIDE and RISE Phase III clinical trials.
