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Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic Retinopathy

Fri, 08/08/2014 - 11:39am

Genentech, a member of the Roche Group, today announced that the company has submitted a supplemental Biologics License Application (sBLA) for Lucentis ® (ranibizumab injection) to the U.S. Food and Drug Administration (FDA) for the treatment of diabetic retinopathy. The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for this serious eye disease. There are currently no ocular medications approved for the treatment of diabetic retinopathy.

Diabetic retinopathy is the most common diabetic eye disease, impacting nearly 7.7 million Americans. The longer a person has diabetes, especially if it is poorly controlled, the higher the risk for developing diabetic retinopathy. It eventually affects nearly all diabetes patients and if left untreated, can lead to blindness. This eye disease is the leading cause of new cases of blindness in working-age Americans. More than 29 million Americans have diabetes.

“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, M.D., chief medical officer and head of Global Product Development. “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.”

Diabetic retinopathy is caused by changes in the blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision. In its early stages, diabetic retinopathy is often without symptoms.

During the RISE and RIDE trials, a clinically significant proportion of diabetic retinopathy patients treated with Lucentis showed meaningful improvements in their disease at two years compared to patients treated with sham injections (control group). The benefits of Lucentis on the signs of diabetic retinopathy were maintained during the third year of treatment.

Lucentis was the first FDA-approved medicine for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy. It was approved August 10, 2012.

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