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GEN News Highlights : Aug 13, 2012

FDA Approves Lucentis for Diabetic Macular Edema

Roche’s Lucentis (ranibizumab injection) has become the first drug to achieve FDA approval as a treatment of diabetic macular edema (DME). The recombinant humanized monoclonal antibody fragment is a VEGF-A inhibitor that has previously been cleared for use in the treatment of visual impairment due to DME in over 75 countries, and is also approved in the U.S. and over 100 countries for treating wet age-related macular degeneration (wet AMD), and macular edema following retinal vein occlusion (RVO).

The Phase III program for DME indication included two identical placebo-controlled studies, Rise and Ride, involving 759 patients randomized to receive either one of two doses of Lucentis monthly, or placebo. The results showed that Lucentis therapy led to visual improvements within seven days, and at two years up to 45% of the antibody-treated patients were able to read at least three additional lines on an eye chart than they could at baseline. This compared with only 12% and 18% of patients in the control groups of the two trials. The average gain in vision exceeded two lines, and visual improvements at 24 months were maintained with continued treatment through to 36 months.

“For the first time, Americans with DME will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision,” comments Hal Barron, M.D., CMO, and head of global product development at Roche. “We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication.”