Lucentis receives Health Canada approval for treatment of retinal vein occlusion

Marks first approved treatment of its class for sudden-onset visual impairment with very few previous treatment options

Following a priority review, Health Canada has approved Lucentis (ranibizumab) as a treatment for vision loss resulting from retinal vein occlusion (RVO). This makes Lucentis the first approved treatment of its class in Canada for this debilitating condition. Patients will now have access to a treatment that is proven to be effective and has an established safety profile.

Approximately 27,000 Canadians suffer from RVO every year making RVO the second-most common cause of vision loss due to retinal vascular disease after diabetic retinopathy.

"The approval of Lucentis for patients afflicted by RVO is an important development that meets a large unmet need," said Dr. Alan Cruess, Head of the Department of Ophthalmology and Visual Sciences of the Faculty of Medicine at Dalhousie University, Halifax, Nova Scotia. "RVO is like having a stroke in the eye and as such its impact can be profound, causing sudden and severe vision loss that greatly impacts patients' lives. Lucentis provides an effective and proven treatment option to restore lost vision for patients for a condition where virtually nothing existed before."

RVO has a sudden-onset, in which patients suffer rapid loss of vision leading to difficulties performing daily activities such as reading, cooking and driving. RVO results from a blockage forming in a blood vessel in the retina, the light-sensitive layer at the back of the eye. In a majority of cases it is caused by the same cardiovascular risk factors that can cause vessel blockages elsewhere in the body, leading to heart attacks or stroke.

"The approval of Lucentis for RVO is a major milestone for patients. RVO changed my life in a 'blink of an eye' by taking a major part of my sight more than a decade ago. At that time there was little that could be done to treat this acute and sudden condition," said Louise Gillis, President of the Canadian Council of the Blind (CCB). "I have learned to live with the effects of RVO with the aide of peer mentoring through CCB, but I am thrilled that many others will now be able to regain their vision and maintain independence thanks to this long-awaited and much-needed treatment."

Lucentis has been approved to treat visual impairment due to macular edema secondary to both types of RVO - branch RVO (BRVO) and central RVO (CRVO). In CRVO, the blockage occurs in the main retinal vein in the optic nerve. In BRVO, the blockage occurs in one of the four branches of the main retinal vein. Both types can lead to swelling of the macula, the central portion of the retina responsible for sharp central vision. This swelling of the macula, or macular edema, is the most common cause of visual impairment in patients with RVO.

RVO often leads to increased production of vascular endothelial growth factor (VEGF), a protein that plays a critical role in leakage of fluid from blood vessels and the formation of new blood vessels under the macula and which can increase RVO complications, including macular edema. Lucentis is specifically designed for use in the eye to bind and inhibit VEGF-A.

Source:

NOVARTIS PHARMACEUTICALS CANADA INC.

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