Genentech (RHHBY) Receives FDA Priority Review for Lucentis as mCNV Treatment
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FDA Grants Priority Review to Genentech’s Lucentis® (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization
October 11, 2016 1:00 AM EDTSOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis® (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. The sBLA is based on results from the Phase III RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic... More