The primary endpoint has been met in one of two phase 3 studies evaluating monthly ranibizumab injection (Lucentis, Genentech) in patients with diabetic macular edema (DME), according to the company.
South San Francisco-The primary endpoint has been met in one of two phase III studies evaluating monthly ranibizumab injection (Lucentis, Genentech) in patients with diabetic macular edema (DME), according to the company.
In the RISE study, a significantly higher percentage of patients receiving monthly ranibizumab saw an improvement in best-corrected visual acuity of at least 15 letters on the eye chart at 24 months, compared with those in a control group, who received a placebo injection. A preliminary analysis of the data did not reveal any unexpected safety signals; further analyses are ongoing.
“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, MD, chief medical officer and head of global product development for Genentech. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”
RISE and RIDE are two identical, parallel confirmatory studies designed to support application to the FDA for a potential new indication for ranibizumab for DME.
In the United States, ranibizumab is approved for the treatment of neovascular age-related macular degeneration and for the treatment of macular edema following retinal vein occlusion. In Europe, where the drug is marketed by Novartis, it recently was approved to treat visual impairment due to DME.