FDA Approves Lucentis for the Treatment of Macular Edema

June 24, 2010

FDA approves Genentech's Lucentis

After a six-month priority review, the US Food and Drug Administration has approved a new indication for Lucentis (ranibizumab injection), developed by Genentech, a member of the Roche group. Lucentis now can be used for the treatment of macular edema following retinal vein occlusion (RVO). Lucentis was first approved by the FDA in 2006 for the treatment of neovascular (wet) age-related macular degeneration.
RVO affects more than 1 million people in the US and is the second-most common cause of vision loss because of retinal vascular disease, which can develop over a long period of time or occur suddenly. Lucentis binds to and inhibits vascular endothelial growth factor A (VEGF-A), a protein that is believed to play a critical role in neovascularism and leakage that contribute to macular swelling after RVO.