FDA approves Lucentis to treat diabetic macular edema
Third indication to be given green light for drug developed by Genentech
The US Food and Drug Administration (FDA) has approved Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), an eye condition that can cause blindness.
According to the US Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects about 26 million people in the US and is the leading cause of new blindness among people ages 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.
Hal Barron, chief medical officer and head of Global Product Development at Genentech, a division of Swiss pharmaceutical manufacturer Roche Group, said: ‘For the first time, Americans with DME will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision.’
‘We developed Lucentis to treat diseases of the eye and are pleased to have received this third US indication to help a new population of people whose eyesight may be affected by diabetes.’
Lucentis is already approved for wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula.
The drug is also approved for macular edema following retinal vein occlusion, a blockage of the small veins that carry blood away from the retina that can cause fluid to leak into the macula.
