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Lucentis Meets Phase III Endpoint in DME

Genentech’s Phase III study evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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Genentech’s Phase III study evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that can lead to blurred vision, severe vision loss and blindness. The RISE study showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision of at least 15 letters on the eye chart at 24 months, compared to placebo. A preliminary analysis of the data did not reveal any unexpected safety signals.

“DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”

Lucentis was recently approved for treatment of visual impairment due to DME in Europe, where it is marketed by Novartis. In the U.S., Lucentis was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006 and more recently for treatment of macular edema following retinal vein occlusion (RVO) in June 2010. RISE and RIDE are two identical, parallel confirmatory studies designed to support the application to the FDA for Lucentis in DME.

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