The FDA has approved once-monthly, 0.3-mg ranibizumab injection (Lucentis, Genentech) for treatment of diabetic macular edema (DME), making it the first and only drug approved by the agency for the condition. The standard of care for DME for the past 25 years has been laser surgery.
South San Francisco-The FDA has approved once-monthly, 0.3-mg ranibizumab injection (Lucentis, Genentech) for treatment of diabetic macular edema (DME), making it the first and only drug approved by the agency for the condition. The standard of care for DME for the past 25 years has been laser surgery.
“We developed [ranibizumab] to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes,” said Hal Barron, MD, chief medical officer and head of global product development for Genentech.
The FDA approved a dose of 0.5 mg once monthly of the vascular endothelial growth factor inhibitor for the treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010. Outside the United States, ranibizumab has received regulatory approval for treatment of DME in more than 75 countries, for treatment of wet AMD in more than 100 countries, and for treatment of RVO in more than 70 countries.
The drug was discovered by Genentech and is being developed by that company and Novartis for diseases or disorders of the eye. Genentech retains commercial rights in the United States, and Novartis has exclusive commercial rights for the rest of the world.
The approval of the recombinant humanized monoclonal antibody fragment for DME was based on two parallel, double-masked, 3-year phase III clinical trials, RIDE and RISE, which were sham-treatment controlled for 24 months. A total of 759 patients were randomly assigned into three groups to receive monthly treatment with 0.3 mg of ranibizumab, 0.5 mg of the drug, or sham injection.
Primary outcomes were evaluated at 24 months and were published in Ophthalmology. Treatment with ranibizumab demonstrated improved clinical outcomes, including substantial visual gain for many DME patients. The most common side effects occurring at a higher rate in patients receiving 0.3 mg ranibizumab compared with the control groups included conjunctival hemorrhage (47% in the 0.3-mg dose versus 32% in the control group), eye pain (17% 0.3 mg versus 13%, control), foreign body sensation in eyes (10% 0.3 mg versus 5% control) vitreous floaters (10% 0.3 mg versus 4% control), and increased IOP (18% 0.3 mg versus 7% control).
Rates of arterial thromboembolic (ATE) events such as vascular death, death of unknown cause, nonfatal heart attack, and nonfatal stroke were similar among patients with DME receiving 0.3 mg ranibizumab and the control groups at 24 months (5.6% 0.3 mg versus 5.2% control). The rate of ATE events at 36 months was 10.8% for patients in the 0.3 mg treatment group (the control period ended at 24 months).
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