FDA Approves Genentech’s Lucentis for Treatment of Diabetic Retinopathy in People with Diabetic Macular Edema

Genentech has announced that FDA has approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME affects nearly 750,000 Americans, about 10% of people with DR.

The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.

"While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy," said Sandra Horning, chief medical officer and head of Global Product Development. "With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision." 

Almost 29 million Americans have diabetes. The longer people have diabetes, especially if it is poorly managed, the higher their risk for developing DR. It is caused by elevated blood sugar levels damaging the fine blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision.

DR with DME is a common diabetic eye disease and a leading cause of blindness in American adults under 55. DR with DME can lead to conditions that threaten vision.

In 2012, Lucentis was the first medicine approved by the FDA for the treatment of DME. Lucentis has also been an important option for patients with wet age-related macular degeneration (wet AMD) since 2006 and macular edema following retinal vein occlusion (RVO) since 2010.