Genentech, a member of the Roche Group (RHHBY.PK), said Thursday that the U.S. Food & Drug Administration Dermatologic & Ophthalmic Drugs Advisory Committee voted 10-0 to recommend approval of the 0.3 mg dose of Lucentis for treatment of diabetic macular edema.
The majority of the panel also recommended the 0.5 mg dose.
The panel's 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 diabetic macular edema. 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.
The FDA is expected to make a decision regarding the supplemental Biologics License Application for Lucentis in diabetic macular edema by August 10.
The FDA generally follows advisory committee recommendations, although it is not bound to do so.
Diabetic macular edema 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 diabetic macular edema in the U.S. is laser surgery, which mainly serves to slow the progression of vision loss and help stabilize vision.
Lucentis was first approved by the FDA for treatment of wet age-related macular degeneration in 2006 and for macular edema following retinal vein occlusion in 2010.
| || |
| To receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio|
by RTT Staff Writer
For comments and feedback: firstname.lastname@example.org