Industry News — Clinical Updates
Lucentis Granted Priority Review by FDA for Treating Diabetic Retinopathy
The US Food and Drug Administration (FDA) has accepted to file a supplemental Biologics License Application (sBLA) and granted Priority Review of Lucentis (ranibizumab, Genentech, South San Francisco, CA) for the treatment of diabetic retinopathy. The sBLA was submitted August 7, 2014, and the FDA’s confirmed action date is February 6, 2015.
Priority Review designation is granted by the FDA to medicines that, if approved, would have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
If approved, ranibizumab could be the first eye medicine available for diabetic retinopathy patients.
The sBLA submission is based on results of the RISE and RIDE phase 3 trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with ranibizumab at 2 years compared to patients treated with sham (control group). Benefits of ranibizumab were maintained during year 3 of treatment and the safety in the RISE and RIDE phase 3 trials was consistent with previous studies.
RISE and RIDE are two identically-designed, parallel, double-masked, sham treatment-controlled trials in 759 patients with diabetic retinopathy and diabetic macular edema (DME) at baseline who were randomized into 3 groups to receive monthly treatment of 0.3 mg ranibizumab, 0.5 mg ranibizumab, or sham injection. The primary objective of the trials was to evaluate the safety, tolerability, and efficacy of ranibizumab in DME patients as measured by the primary efficacy endpoint of percentage of subjects gaining ≥ 15 letters in best corrected visual acuity (BCVA) score compared with baseline at 24 months.
The efficacy of ranibizumab for the treatment of diabetic retinopathy was also assessed over 3 years in RISE and RIDE patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in the study eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. At Month 24, an exploratory analysis demonstrated a higher proportion of patients treated with ranibizumab had observed a 3-step or more improvement of disease compared to sham, as determined by color fundus photography. In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5 mg ranibizumab; patients originally randomized to 0.3 mg or 0.5 mg ranibizumab continued to receive their assigned dose and patients were followed for 12 additional months. The benefits of ranibizumab treatment achieved at month 24 were maintained through month 36.
Updated October 8, 2014