Lucentis ranibizumab regulatory update

Novartis said it submitted a regulatory application in October in the EU for Lucentis ranibizumab to treat retinal vein occlusion (RVO). The humanized mAb fragment against VEGF-A is already approved in the U.S. and Europe to treat wet age-related macular degeneration (AMD), and in the U.S. for macular edema following RVO. In October, the CHMP issued a positive opinion on an MAA to extend the indication of Lucentis to treat visual impairment due to diabetic macular edema (DME) (see BioCentury, Oct. 25). ...