Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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.

Register
To receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Consumer prices in the U.S. unexpectedly showed a modest increase in the month of September, according to a report released by the Labor Department on Wednesday, with higher prices for food and shelter offsetting a continued decline in energy prices. The European Parliament has given its strong support to the new European Commission with 423 votes in favor, 209 against and 67 abstentions. The approval was crucial for the Juncker Commission to start a five-year term on 1 November. Today's vote marks the last step in the process leading up to the new European Commission. The European Cabinet has a representative each from all 28 EU member states After moving notably higher over the past few sessions, stocks may show a lack of direction in early trading on Wednesday. The major index futures are currently pointing to a roughly flat open for the markets, with the Dow futures up by just 5 points.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.