OCT 10, 2014
Comprehensive Ophthalmology, Retina/Vitreous
The U.S. FDA has granted priority review for Lucentis (ranibizumab) for the treatment of diabetic retinopathy. The FDA confirmed action date is Feb. 6, 2015.
Genentech submitted a supplemental Biologics License Application to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy.
Priority Review status is granted to medicines that, if approved, have the potential to significantly improve the safety or efficacy of treatment of serious conditions, compared to standard applications.
Genentech’s submission is based on results from the RISE and RIDE trials, which showed meaningful improvements in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. The benefits were maintained during year three of treatment, and the safety in the RISE and RIDE trials was consistent with previous studies.
Lucentis was approved for diabetic macular edema in August 2012, based on the RISE and RIDE trials.