The FDA has accepted the supplemental Biologics License Application and granted Priority Review for Lucentis (ranibizumab injection) for treatment of diabetic retinopathy, according to a press release from Genentech.
Data from the phase 3 RISE and RIDE trials formed the basis of the sBLA submission.
In the parallel, double masked, controlled trials, 759 patients with diabetic retinopathy and diabetic macular edema were randomly assigned to receive Lucentis 0.3 mg monthly, Lucentis 0.5 mg monthly or sham injection.
After 2 years of treatment, significantly more patients treated with Lucentis experienced meaningful improvement in their eye disease. Benefits were maintained out to 3 years, according to information in the release.
Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, became the first FDA-approved medicine for diabetic macular edema in 2012 based on data from the RISE and RIDE trials. It is also currently approved for treatment of wet age-related macular degeneration and macular edema following retinal vein occlusion.
A decision from the FDA is expected by Feb. 6, 2015.