[Nfbf-l] More on the Vision-Restoring Retinal Prosthesis Receives FDA Approval News

[Alan Dicey]

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.


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 the Food 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.