Industry News — Clinical Updates

Genentech Submits sBLA for Lucentis for Treating Diabetic Retinopathy

Genentech (South San Francisco, California) announced that it has submitted a supplemental Biologics License Application (sBLA) for Lucentis (ranibizumab) to the US Food and Drug Administration (FDA) for the treatment of diabetic retinopathy. The submission is based on results of RISE and RIDE Phase 3 clinical trials, which demonstrated safety and efficacy of ranibizumab for treating diabetic retinopathy. 

During the RISE and RIDE trials, a clinically significant proportion of diabetic retinopathy patients treated with ranibizumab showed meaningful improvements in their disease at 2 years compared to patients in the sham arms (control groups).

RISE and RIDE are identically designed, parallel, double-masked, sham treatment-controlled trials consisting of 759 diabetic retinopathy and diabetic macular edema patients at baseline. Patients were randomized into 3 groups to receive monthly 0.3 mg ranibizumab, 0.5 mg ranibizumab, or sham injection.

Safety and efficacy was assessed over 3 years in patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in the study eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) grading scale. Primary outcomes, which were evaluated at 24 months, demonstrated that a higher proportion of patients had observed a 3-step or better improvement of disease compared to sham, as determined by color fundus photography. 

Updated August 8, 2014