Genentech today announced that the U.S. Food & Drug Administration (FDA) voted unanimously to recommend approval of Lucentis® for treatment of diabetic macular edema (DME).
DME 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 DME in the U.S. is laser surgery, which primarily serves to slow the progression of vision loss and help stabilize vision.
Nearly 26 million Americans have diabetes which has become the leading cause of new cases of blindness in adults aged 20-74.
“The committee’s recommendation is an important step towards the goal of helping to redefine the standard of care for Americans with diabetic macular edema,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision.”
Lucentis was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010. Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye.
Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy, according to the 2005-2008 National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics. It has also been estimated that up to 10 percent of people with diabetes will get DME during their lifetime.
DME 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 DME in the U.S. is laser surgery, which primarily serves to slow the progression of vision loss and help stabilize vision.
Nearly 26 million Americans have diabetes which has become the leading cause of new cases of blindness in adults aged 20-74.
“The committee’s recommendation is an important step towards the goal of helping to redefine the standard of care for Americans with diabetic macular edema,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision.”
Lucentis was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010. Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye.
Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy, according to the 2005-2008 National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics. It has also been estimated that up to 10 percent of people with diabetes will get DME during their lifetime.
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