« Return to News | Clinical Intelligence

FDA approves Lucentis for diabetic macular edema

Monday, August 13, 2012 10:33 AM

The FDA has approved Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

The FDA previously approved Lucentis to treat wet (neovascular) age-related macular degeneration (AMD), as well as macular edema following retinal vein occlusion. An injection administered once a month by a health care professional, the new approval of Lucentis for DME is intended to be used along with good diabetic blood sugar control.

The drug’s safety and effectiveness to treat DME were established in two clinical studies involving 759 patients who were treated and followed for three years. Patients were randomly assigned to receive monthly injections of Lucentis at 0.3mg or 0.5mg, or no injections during the first 24 months of the studies. After 24 months, all patients received monthly Lucentis either at 0.3 mg or 0.5 mg.

The studies measured the number of patients who gained vision, as measured on an eye chart. Results showed that between 34% and 45% of those treated with monthly Lucentis 0.3mg gained at least three lines of vision compared with 12% to 18% of those who did not receive an injection. No additional benefit was observed with the higher monthly Lucentis dose of 0.5mg.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.