FDA Advisory Committee recommends Lucentis (Genentech) for treatment of Diabetic Macular Edema - 30-Jun-2012

The FDA Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) from Genentech/Roche for treatment of Diabetic Macular Edema (DME). The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so.

The DODAC recommendation was based on a review of data from Genentech’s Phase III trials, RIDE and RISE, which evaluated the efficacy and safety of Lucentis in people with DME. The primary endpoint was the percentage of patients who could read an additional 15 letters or more on the standard eye chart after 24 months of treatment compared to the percentage in a control group. Lucentis is approved in Europe for this indication.