FDA Grants Priority Review to Genentech's Lucentis-Ranibizumab Injection for Myopic CNV

Genentech, a member of the Roche Group , 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 therapy, the only treatment currently approved by the FDA 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.

In mCNV, new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, possibly causing irreversible central vision loss. Symptoms of mCNV include blurred or distorted vision, a sudden progression of central vision loss and difficulty distinguishing colors.

Myopic CNV is believed to affect approximately 41,000 people in the U.S. and is a common vision-threatening complication of pathological myopia, or severe nearsightedness. People between the age of 45 and 64 are more likely to develop mCNV, and the condition affects more women than men. In addition, people with pathological myopia or of East Asian descent are also at an increased risk.