SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has accepted a supplemental Biologics License Application or sBLA and granted Priority Review for Lucentis or ranibizumab injection for the treatment of myopic choroidal neovascularization or 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 therapy, the only treatment currently approved by the FDA for mCNV.
The FDA grants a Priority Review designation to applications for medicines that treat serious conditions and, if approved, would provide a significant improvement in safety or efficacy. If approved, Lucentis would be the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV.
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