FDAnews Drug Daily Bulletin

A panel of FDA advisors called for swift approval of Genentech’s sBLA for Lucentis to treat diabetic macular edema (DME), saying the drug’s efficacy and safety profile far outweigh any statistical shortcomings. If approved, the drug would be the first sanctioned for the indication. If the agency’s Dermatologic and Ophthalmic Drugs Advisory Committee had any concerns about use of Lucentis (ranibizumab) for the proposed indication Thursday, it was that the sponsor’s two pivotal Phase III trials were too underpowered to show iron-clad proof of safety.
Washington Drug Letter