FDA Grants Priority Review for Lucentis in Diabetic Retinopathy

Genentech has announced that the FDA has granted its submission for Priority Review of Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, 2015. If approved, Lucentis could be the first eye medicine available for diabetic retinopathy patients. Lucentis was also the first FDA-approved medicine for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy.
The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections (control group). Benefits of Lucentis treatment were maintained during year three of treatment.
Read the original press release for more detail.