Vision-Restoring Retinal Prosthesis Receives FDA Approval

February 14, 2013

The Argus II retinal prosthesis, a device that can restore some vision to people who are blind from advanced retinitis pigmentosa (RP), has received U.S. market approval from theFood and Drug Administration (FDA). Developed by Second Sight Medical Products, the device will be available later this year in approximately 10 clinical centers across the country. In 2011, the Argus II received marketing approval in Europe. Also known as a “bionic retina,” it is currently the world’s only retinal prosthesis with regulatory approval.

More than 20 years of research went into the development of the Argus II. The Foundation Fighting Blindness played a seminal role in its development by funding laboratory studies for an earlier version of the device.

“This is truly an exciting and historic moment in the drive to restore vision in people with advanced retinal degenerative diseases,” says Dr. Stephen Rose, chief research officer of the Foundation. “By restoring some basic vision, the Argus II gives people independence, mobility and, ultimately, improved quality of life.”

The Argus II consists of an external video camera mounted on a pair of sunglasses which sends visual images to a 60-electrode grid surgically implanted on the retina. The grid converts those images to electrical signals, which are sent back to the brain.

Users of the device perceive patterns of light, which the brain learns to interpret as vision. The device has enabled clinical trial participants who are profoundly blind from retinal degeneration to see shapes, recognize large letters and significantly improve mobility.

In September 2012, a group of industry experts, Second Sight representatives and six users of the Argus II attended an FDA hearing to request recommendation for marketing approval. The users spoke compellingly about how the device improved their ability to navigate and accomplish daily tasks. Dean Lloyd, an attorney who is completely blind from RP, told the panel about his delight in being able to sort white, grey and black socks, thanks to the Argus II.

Further information about costs and availability of the Argus II will be provided by Second Sight later this year. The company is actively pursuing insurance reimbursement for the system.

Second Sight is in the early stages of developing a 240-electrode retinal prosthesis designed to enable users to perceive more detail. Clinical availability is years away, and, in the meantime, the company intends to boost patient performance of the Argus II by upgrading the camera and software of the externally worn part of the system.

Read more about the Argus II and its history from an Eye on the Cure blog post written by Dr. Robert Greenberg, Second Sight’s chief executive officer. And to read about the positive impact the Argus II had on one man’s life, check out this story.

For more information on the Argus II or to learn if you may be a candidate for this device, call the Second Sight Medical Products hotline at 855-756-3703 (toll free) or 818-833-5027.