FDA Grants Priority Review for Myopic CNV Treatment

Genentech, makers of Lucentis® (ranibizumab injection) for wet AMD, has been approved for Priority Review by the FDA to study Lucentis for the treatment of myopic choroidal neovascularization (mCNV). Also known as degenerative myopia, mCNV is a complication of severe near-sightedness that can lead to uncorrectable visual impairment. The FDA’s approval is based on results from the Phase III RADIANCE study demonstrating Lucentis as superior to photodynamic therapy (PDT), the only treatment currently approved for mCNV.
“With the current FDA-approved therapy, people with myopic choroidal neovascularization achieve only temporary stabilization of vision, while mCNV patients treated with Lucentis in the RADIANCE study experienced significant improvement of their vision,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The filing acceptance and Priority Review for Lucentis brings us one step closer to a potential new option for people with this serious eye condition.”
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.
About the RADIANCE study