Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.
“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”
The study, known as RISE, showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision (BCVA) of at least 15 letters on the eye chart at 24 months, compared to those in a control group, who received a placebo (sham) injection. BCVA is best corrected visual acuity, the best possible vision a person can achieve with corrective lenses, as measured by reading the eye chart. A preliminary analysis of the data did not reveal any unexpected safety signals and further analyses are ongoing. Topline results from the RISE study will be presented at the 34th Annual Macula Society Meeting, on March 10, 2011 in Boca Raton, Florida.
"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 United States (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 application to the U.S. Food & Drug Administration (FDA) for a potential new indication for Lucentis for DME.