Lucentis receives Health Canada approval to treat vision loss from DME

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First approved treatment of its class for the most-feared complication of diabetes and a leading cause of vision loss in working-aged adults

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 and an important complication of the growing epidemic of diabetes.

For diabetics, the possibility of losing their eyesight is the most feared complication of their diabetes.  Visual impairment due to DME reduces patients' 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.

An estimated 2.5 million Canadians have diabetes. And like its parent disease, the sight-robbing condition DME does not discriminate against age. In fact, of the more than 70,000 Canadians whose vision is currently affected by DME, a significant number are of working age, with a recent study enrolling patients as young as 30.

Laser therapy, the current standard of care, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first approved therapy to improve vision for patients with visual impairment due to DME.

"Lucentis provides us for the first time a real opportunity to improve vision in persons with DME," said Dr. Peter Kertes, a vitreo-retinal surgeon and Ophthalmologist-in-chief of the John and Liz Tory Eye Centre at Sunnybrook Health Sciences Centre and Associate Professor in the Department of Ophthalmology and Vision Sciences at the University of Toronto. He was also an investigator in the studies that were reviewed by Health Canada for the approval of Lucentis for this condition. "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."

One of the Canadian patients in the international trials studying Lucentis in DME was Kash Joshi of Toronto. Diagnosed with diabetes in 1994, several years ago he started having troubles with blurry vision, which continued even after cataract surgery, at which point he enrolled in the Lucentis study. "I noticed an improvement after the first injection, and it's kept on getting better," he said. "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."

Lucentis was specifically developed as a treatment for visual impairment due to its effect on a protein that plays a critical role in the leakage of blood vessels in the retina of diabetic patients. Macular edema is a swelling of the macula from leaking of fluid from blood vessels, resulting in blurred vision. In the clinical trial RESTORE, Lucentis has been shown to significantly improve vision compared to laser therapy, the current standard of care.

Source:

NOVARTIS PHARMACEUTICALS CANADA INC.

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