JDRF-Funded Treatment for Diabetic Eye Disease Moves Ahead to Regulatory Review in Europe
NEW YORK, Dec. 10, 2009 — A promising drug for diabetes-related eye disease has moved along the drug development pipeline considerably ahead of schedule in Europe.
Novartis Pharmaceuticals, based in Switzerland, announced that the drug Lucentis has been submitted to the European Union’s regulatory agency, European Medicines Agency (EMEA), for approval for the treatment of diabetic macular edema. The submission is based on strong, positive results from Phase II clinical trials, including ones funded by JDRF. Macular Edema is a major complication of diabetes that often leads to vision loss and blindness.
According to JDRF, this is remarkable progress towards the approval of the first disease-modifying drug for a diabetes complication. Lucentis is currently approved in the United States and Europe for treating age-related macular degeneration.
JDRF has been involved with the development of Lucentis for diabetic eye disease for years, beginning with an Innovative Grant. JDRF then collaborated with Genentech, a biotech company based in South San Francisco, and Johns Hopkins Medical School to conduct clinical research on the drug, combining standards of care and other factors to help unlock the full therapeutic benefit of the drug for people with type 1 diabetes.
Lucentis works by blocking the effects of a protein called VEGF, which causes the tiny vessels in the eye to leak and promotes new vessel growth.
About Diabetic Macular Edema
Currently, there are no approved vision-improving therapies for diabetic eye disease. Diabetic retinopathy is the most common cause of blindness. Approximately 25 percent of patients with diabetes have retinopathy that results in legal blindness. The most common cause of visual loss in people with diabetic retinopathy is diabetic macular edema.
JDRF is the leader in research leading to a cure for type 1 diabetes in the world. It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.
The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump – each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including more than $100 million in 22 countries in FY2009.