FDA Approves Genentech Medicine for Diabetic Retinopathy in People with Diabetic Macular Edema

February 6th, 2015

On February 6, 2015, the FDA approved Lucentis® (ranibizumab) for the treatment of diabetic retinopathy in people with diabetic macular edema (DME).


News in brief

  • First eye medicine approved for treatment of diabetic retinopathy with diabetic macular edema
  • Granted Breakthrough Therapy Designation and Priority Review by FDA
  • Diabetic macular edema can occur at any stage of diabetic retinopathy, a leading cause of blindness in American adults
  • Fourth Lucentis indication for treatment of serious eye diseases since 2006

Supporting Information

Sandra Horning, M.D.

“While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy. 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.”