Health Canada Approves Second Sight’s Argus II Retinal Prosthesis System

Second Sight Medical Products Inc. has received Health Canada approval of its Argus II Retinal Prosthesis System for the outer retinal degeneration treatment.

The Argus II, implanted in more than 100 individuals worldwide, is the only retinal prosthesis approved by Health Canada and the U.S. Food and Drug Administration (FDA), and the first approved retinal prosthesis in the world, according to Second Sight. The system induces visual perception in blind individuals by providing electrical pulses to stimulate the retina’s remaining cells, resulting in a perception of light patterns in the brain. The Argus II has the potential to offer visual capabilities to those with little or no remaining functional vision. The Argus II implant can positively impact a blind person’s ability to conduct routine daily activities, such as recognizing shapes or large objects, locating people, identifying the location of doorways, and following lines or edges, the company claims. Ultimately, this is meant to allow Argus II users to live their daily lives with more confidence.

“This is one of the most exciting medical developments I have witnessed in my career,” said Robert Devenyi, M.D., F.A.C.S., ophthalmologist-in-chief at the Donald K. Johnson Eye Centre and director of retinal services, at University Health Network. “The Argus II offers so much hope and possibility for patients with degenerative eye disease. I am delighted to be part of the first team in Canada that can provide this technology to patients.”

Devenyi implanted the Argus II in the first Canadian patient last June at Toronto Western Hospital in Toronto, Ontario, as part of an investigator-sponsored study.

“This regulatory approval and the first implants of the Argus II in Canada are tremendous milestones, not only for Second Sight, but also for those affected by outer retinal degenerations in Canada,” stated Robert Greenberg, M.D., Ph.D., president and CEO of Second Sight. “Leveraging more than 20 years of research and development, supported by strong intellectual property, and coming on the heels of our approval in the U.S., this [Canadian] approval enables us to expand our international network of Centers of Excellence, which offer the Argus II retinal implant, into additional Canadian provinces beyond Ontario.”

Second Sight currently is recruiting additional centers in major metropolitan areas and plans to apply for reimbursement in the provinces where they are established.

Outer retinal degeneration is the deterioration of the outer layer of the retina (e.g. the photoreceptors), caused by the progressive death of the cells in this region of the retina. An important type of outer retinal degeneration is Retinitis Pigmentosa, a rare, hereditary disease that causes a progressive degeneration of the light-sensitive cells of the retina, leading to significant visual impairment and ultimately can lead to blindness. There are an estimated 13,000 people in Canada and 1.2 million people worldwide with RP.

Second Sight Medical Products was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer-retinal degenerations such as RP. The company also is developing the Orion cortical prosthesis to restore vision to individuals who are blind due to causes other than preventable or treatable conditions. The population of people potentially eligible for the future Orion cortical prosthesis in Canada is about 70,000. Second Sight’s U.S. headquarters are in Sylmar, Calif., while it’s European base is located in Lausanne, Switzerland.