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FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.
Genentech announced on Oct. 8, 2014 that it received Priority Review from FDA for the diabetic retinopathy, Lucentis. Priority Review is granted by FDA to “medicines that, if approved, would have the potential to provide improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.”
Genentech submitted a supplemental biologics license application (sBLA) on Aug. 7, 2014. The submission is based on the results of two Phase III trials, which resulted in improvements in the disease.
The Phase III trials consisted of 759 patients with diabetic retinopathy and Diabetic Macular Edema at baseline, divided into two groups: the RISE trial with 377 patients, and the RIDE trial with 382 patients. The trials were identical, parallel, double-masked, sham treatment-controlled with each trial divided into three random groups with different monthly treatments: 0.3mg Lucentis, 0.5 mg Lucentis, or sham injection.
The trials, conducted over a three-year period, resulted in an increased proportion of patients treated with Lucentis to improve by three or more steps, compared to the sham at month 24. By month 36, the benefits of Lucentis were maintained.