Genentech announced last month that a Phase III study evaluating monthly Lucentis (ranibizumab) in patients with diabetic macular edema (DME), met its primary endpoint.
DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness. The current standard of care for DME is laser surgery that helps seal the leaky blood vessels to slow the leakage of fluid and reduce the amount of fluid in the retina.
The study, known as RISE, showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision (BCVA) of at least 15 letters on the eye chart at 24 months, compared to those in a control group, who received a placebo (sham) injection. Results from the RISE study will be presented at the Macula Society Meeting.
"DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition," said Dr Hal Barron of Genentech.
Lucentis was recently approved for treatment of visual impairment due to DME in Europe. In the United States, Lucentis was approved for treatment of neovascular AMD in 2006 and for treatment of macular edema following retinal vein occlusion in 2010.
WHAT IT MEANS TO YOU: The treatment options for diabetic macular edema continues to grow. Anti-VEGF therapies appear to be very effective, but suffer from short-term benefit and the need for continual retreatment. Sustained release steroid implants (Iluvien) is another recent development for DME. The advantage Iluvien has over Lucentis is that it is administered as a 2-3 year intravitreal implant, rather than repeated intravitreal injections. On the downside, steroid therapy carries a risk of glaucoma and cataract. And there is still the laser photocoagulation option, which has a proven track record of stabilizing vision in patients with DME.Source:http://www.gene.com/gene/news