The approval was based on Genentech’s Phase 3 trials, RIDE and RISE, two identically-designed, parallel, double-masked, three-year clinical trials, which were sham-treatment controlled for 24 months. A total of 759 patients were randomized into three groups to receive monthly treatment with 0.3mg Lucentis (n=250), 0.5mg Lucentis (n=252) or sham injection (control group, n=257). Study results showed treatment with Lucentis resulted in improved clinical outcomes including substantial visual gain for many DME patients.
Lucentis is already approved for treatment of neovascular (wet) age-related macular degeneration and 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.
For more information call (800) 821-8590 or visit www.lucentis.com.