Major Milestone Reached for People with Diabetic Eye Disease
Lucentis® Approved for Diabetic Macular Edema in Europe
NEW YORK, Nov. 5, 2010 – JDRF is pleased to share the news that the first drug that can reverse the effects of diabetes-related eye disease has received approval by authorities in Europe. Novartis Pharmaceuticals announced recently that Lucentis® (ranibizumab injection) was approved for the treatment of diabetic macular edema (DME), a major complication of diabetes that may lead to vision loss and blindness.
According to Barbara Araneo, Ph.D., Director of Complications Therapies for JDRF, “This is an exciting victory for people with diabetic eye disease. We hope that access to vision-improving therapies like this will prompt everyone who has had type 1 diabetes for more than five years to seek annual eye screening, and treatment if necessary.”
Novartis, the developer of Lucentis® in Europe, submitted data to the EMEA in November 2009 based on two company-funded clinical trials, which showed that ranibizumab provided rapid and sustained improvement in visual acuity when compared to a placebo or laser therapy, the current standard of care. Both studies showed that patients treated with ranibizumab alone, or when combined with laser therapy, were able to significantly improve their vision by at least one line on a standard eye chart after one year.
These reports were also supported by pivotal data released earlier this year from an independent Phase II study in the United States that was conducted by the National Eye Institute and the Diabetic Retinopathy Clinical Research Network (DRCR.net). The study showed that after one year, nearly half of the patients in the trial treated with ranibizumab and laser therapy improved their vision by at least two lines on a standard eye chart, concluding that the drug, when combined with the current standard treatment of laser therapy, is more effective and improved vision significantly, compared with laser treatment alone.
The leading cause of visual loss in people with diabetic retinopathy is DME. JDRF’s Complications Program is currently involved with three clinical trials focused on slowing or halting the progression of diabetic eye disease.
“JDRF is interested in creating a better quality of life for people living with diabetes and its complications. This includes working with industry in developing a pipeline of drugs and therapies that can complement this treatment, or be used in people who don’t respond to it,” said Dr. Karin Hehenberger, M.D., Ph.D., Senior Vice President, Strategic Alliances, JDRF.
Other Ongoing Eye Research
Currently, there are no approved vision-improving therapies for diabetic eye disease in the U.S.
Lucentis®(ranibizumab), developed by Genentech in the United States, is currently approved by the U.S. Food and Drug Administration (FDA) for treatment of age-related macular degeneration, another serious condition that potentially could lead to blindness. Two ongoing Phase III trials in the U.S. testing Lucentis for the treatment of diabetic macular edema are near completion, and its results are expected to help form the basis of the FDA’s decision to approve the drug for diabetic eye disease.
In addition to laser therapy, which is the current standard of care, other treatments for diabetes-related eye disease are also emerging. Currently, a steroid implant developed by Alimera, is under review by the FDA.
About Diabetic Macular Edema
Diabetic macular edema (DME) is swelling in the center of the retina, the light-sensitive tissue that lines the back of the eye and provides detailed vision for activities such as reading, driving, or distinguishing faces. Swelling results from damage to the small blood vessels in the retina after years of elevated blood sugar levels from diabetes and can lead to vision loss if untreated.
DME affects approximately 28% of people who have had diabetes for at least 20 years. The standard treatment of DME for at least 25 years has been laser treatment of areas with abnormal blood vessels. The treatment reduces the progression of the disease, but does not improve vision.
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 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.
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JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is now the largest charitable supporter of T1D research. The goal of JDRF research is to improve the lives of all people affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal.
Since its founding in 1970, JDRF has awarded more than $1.7 billion to diabetes research. Past JDRF efforts have helped to significantly advance the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. More than 80 percent of JDRF’s expenditures directly support research and research-related education.