Phase 3 study of Lucentis for diabetic macular edema

Genentech announced positive results from a Phase 3 trial of monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME). The study, known as RISE, is a multicenter, randomized, double-masked, sham injection-controlled, 36-month study in 377 patients with DME. Study data showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision, best corrected visual acuity (BCVA), of at least 15 letters on the eye chart at 24 months, compared with those in a control group, who received a placebo (sham) injection.

Lucentis is already approved for treatment of neovascular (wet) age-related macular degeneration for treatment of macular edema following retinal vein occlusion (RVO). Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF, a protein that is believed to play a critical role in angiogenesis and the hyperpermeability of the vessels. In wet AMD, these blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula, the portion of the eye responsible for fine, detailed central vision. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula.

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