Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for its treatment of diabetic retinopathy, ranibizumab injection (Lucentis).
The submission is based on results of the RISE and RIDE phase III clinical trials demonstrating the safety and efficacy of the treatment for diabetic retinopathy.
“As the number of people impacted by diabetes continues to rise, so too will the number of people affected by diabetic eye disease,” said Sandra Horning, MD, chief medical officer and head of global product development for Genentech. “We are committed to helping more people with diabetes prevent vision loss and look forward to continuing our discussions with the FDA about these data.”
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 with patients treated with sham injections (control group).
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The benefits of ranibizumab on the signs of diabetic retinopathy were maintained during the third year of the treatment.
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