Genentech announced that the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose.
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 committee’s recommendation is an important step towards the goal of helping to redefine the standard of care for Americans with diabetic macular edema,” said Hal Barron, MD, chief medical officer and head, Global Product Development. “There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision.”
DME is an eye condition in people with diabetes characterized by retinal swelling and blurred vision. It is a major cause of vision loss and blindness estimated to affect more than 560,000 people in the United States. The current standard of care for DME in the U.S. is laser surgery, which primarily serves to slow the progression of vision loss and help stabilize vision.
The DODAC recommendation was based on a review of data from Genentech’s Phase 3 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 was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010.
Date: July 26, 2012
Filed Under: Drug Discovery