FDA Approves First New Therapy for Diabetic Macular Edema in 25 Years
By Catherine Schaffer
The FDA today approved Lucentis (ranibizumab injection) for diabetic macular edema, offering patients the first improvement on the standard-of-care in 25 years.
Lucentis, a VEGF inhibitor marketed by Genentech Inc., a unit of Roche AG, of Basel, Switzerland, is already approved for neovascular age-related macular degeneration and macular edema following retinal vein occlusion at a 0.5 mg dose, and the FDA's Dermatologic and Opthalmic Drug Advisory Committee (DODAC) supported it unanimously in the new indication.
According to Genentech, about 25.8 million Americans, or 8.3 percent of the population, have diabetes and are vulnerable to diabetic macular edema as the disease slowly damages the blood vessels of the eye.
The current standard of care for DME is laser treatment, which reduces the rate of vision loss but does not reverse it.
Lucentis is believed to decrease retinal edema by decreasing retinal capillary permeability.
In two Phase III trials, Lucentis met its primary endpoint of achieving a percentage of patients who gained at least 15 letters (three lines on a standard eye chart) of vision from baseline at 24 months.
In a group treated with 0.3 mg Lucentis, 39.2 percent gained 15 letters of vision. At the 0.5 mg dose, 42.5 percent hit the benchmark. Only 15.2 percent of patients in the sham injection control group had that great an improvement in their vision.
See Monday’sBioWorld Today for More on This Story.
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