FDA approves fifth indication for Lucentis

Roche announced that Lucentis (ranibizumab) 0.5 mg has been granted approval by FDA for the treatment of mCNV (myopic choroidal neovascularization), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first VEGF product approved by FDA to treat this condition. The approval is based on the results of the Phase III RADIANCE trial, which demonstrated that treatment with Lucentis provided better results on vision in this patients population vs vPDT (verteporfin photodynamic therapy). The condition affects approximately 41,000 people in the US. People with pathological myopia who are between the age of 45 and 64 are more likely to develop mCNV. The disease affects more women than men. (Source Roche press release)