Health Canada approves treatment for diabetic macular edema (DME)
Sept 14, 2011 – Health Canada has approved Lucentis® (ranibizumab) as a treatment for vision loss resulting from diabetic macular edema (DME), one of the major causes of adult vision loss. Lucentis® was approved earlier this year for the treatment for vision loss due to retinal vein occlusion and is well established as a treatment for wet AMD.
An estimated 2.5 million Canadians have diabetes. It affects people of all ages, and the numbers of affected people are growing rapidly in Canada. Vision loss due to diabetic macular edema is one of the most feared complications for people living with diabetes. Visual impairment due to DME reduces people’s quality of life by compromising various activities such as ability to work, read and drive. DME is a consequence of diabetic retinopathy which usually progresses slowly with worsening symptoms and impact on vision.
Dr. Peter Kertes is a vitreo-retinal surgeon and ophthalmologist-in-chief at Toronto’s Sunnybrook Health Sciences Centre. He treats people with diabetic macular edema and was also part of the clinical trials testing the use of Lucentis® for this condition. “Lucentis® provides us for the first time a real opportunity to improve vision in persons with DME,” he says. “In one study, after 12 months a significantly greater proportion of patients treated with Lucentis® had vision in the treated eye at or above the international legal minimum for driving. This is a major achievement that has a meaningful impact on patients’ lives.”
Kash Joshi of Toronto was one of the Canadian patients in the international trials studying Lucentis® in DME. Diagnosed with diabetes in 1994, several years ago he started having troubles with blurry vision. After enrolling in the Lucentis® study, he “noticed an improvement after the first injection, and it’s kept on getting better. I had given up reading, except for short times with a magnifying glass. Now my eyesight is almost 20/20 and I read and do everything else without a problem. The difference is like night and day.”
“The approval of Lucentis® to treat vision loss from DME is an important step forward in alleviating the burden of adult vision loss in Canada,” said Sharon Colle, President and CEO of The Foundation Fighting Blindness, based in Toronto. “As an organization dedicated to research and finding a cure for retinal diseases, it’s encouraging to see this very positive development. We hope persons with DME will quickly get access to Lucentis® through provincial drug plans.”
Health Canada approval is only the first step in having a drug included on provincial drug plans. While some private insurers will move quite quickly, it can take months, or in some cases, even years for provincial plans to agree to provide approved treatments.