FEB 06, 2015
The U.S. FDA has approved the expanded use of ranibizumab for diabetic retinopathy in patients with diabetic macular edema.
Monthly injections of ranibizumab 0.3 mg should be used in conjunction with appropriate treatments to manage blood pressure, blood sugar and cholesterol.
"With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision," said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech.
The FDA’s approval is based on the RISE and RIDE trials, which showed meaningful improvements in a clinically significant proportion of patients with diabetic retinopathy treated with ranibizumab for 2 years, compared with patients treated with sham injections. The benefits were maintained during year 3 of treatment.