Genentech's Lucentis Is the First Drug to Win Approval for Diabetic Retinopathy
Published: Feb 10, 2015
February 9, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Genentech , a member of the Roche Group, announced on Friday that the U.S. Food and Drug Administration (FDA) approved its drug Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy in people with diabetic macular edema (DME).
The FDA first approved Lucentis in 2012, when the drug became the first medicine approved for the treatment of DME. With this newly approved indication, Lucentis is now the, “first eye medicine approved for treatment of diabetic retinopathy with diabetic macular edema,” according to Genentech.
“While there are various options for treating diabetic macular edema, before today none were [sic] approved showing improvement in retinopathy,” said Sandra Horning, chief medical officer and head of Global Product Development at Genentech, in a statement. “With [this] approval, people with diabetic macular edema now have an FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”
The most common diabetic eye disease, diabetic retinopathy affects about one third of adults with diabetes over the age of forty. “According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years,” the FDA said in the statement announcing the approval of Lucentis for diabetic retinopathy.
“Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement. “[This] approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”
Lucentis received Breakthrough Therapy Designation and Priority Review from the FDA based on results from two Phase III clinical trials, named RISE and RIDE. The trials, designed to be identical, included 759 patients with diabetic retinopathy and DME who received either 0.3 mg of Lucentis, 0.5 mg of Lucentis or a sham injection. By Month 24, a higher proportion of patients who received Lucentis had observed at least a three-step improvement in visual acuity as compared to those who received the placebo.
At the request of Genentech, the FDA reviewed Lucentis for the designation of breakthrough therapy. Because clinical evidence demonstrated that Lucentis offered “substantial improvement over available therapies for patients,” the FDA granted Lucentis Breakthrough Therapy status for the treatment of diabetic retinopathy in people with DME.
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