logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Panel Backs Lucentis For Treatment Of Diabetic Macular Edema

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Facebook Inc. (FB), Wednesday reported a jump in profit for the second quarter, as the social networking giant's bottom line continues to be driven by soaring ad revenues. Both earnings and revenues trumped Wall Street expectations, sending shares up by 6 percent in the extended hours. Menlo Park,... Boeing Co.(BA) reported a loss for the second-quarter 2016 compared to profit in the prior year, reflecting 787 cost reclassification and charges on the 747 program and the KC-46 Tanker program, partially offset by solid execution and higher volume. It cut its profit outlook for fiscal year 2016, while it reaffirmed annual revenue guidance. Automaker Fiat Chrysler Automobiles NV on Wednesday reported a 25 percent increase in profit for the second quarter from last year. However, quarterly net revenues and worldwide shipments declined from last year.
comments powered by Disqus
Follow RTT