Bionic eye implant gets FDA approval
Vision-impaired adults with a rare eye disease may regain the ability to do daily tasks, such as walking on the sidewalk, from the first implanted artificial retina to win U.S. regulatory approval.
Second Sight Medical Products Inc. has received Food and Drug Administration clearance for its Argus II Retinal Prosthesis System, the agency said yesterday.
Argus II helps with advanced retinitis pigmentosa, which damages light-sensitive cells that line the retina, causing a gradual loss of vision and possibly blindness.
While the $100,000-plus system won't restore sight, it does give patients the ability to perceive the difference between light and dark, the FDA said.
The device consists of a video camera, a transmitter mounted on a pair of eyeglasses and a processing unit that transforms images into electronic data that is transmitted to an implanted retinal prosthesis, the FDA said.
"This is a game changer," said Robert Greenberg, president and chief executive of Second Sight, based in Sylmar, Calif.
A clinical study of 30 people showed the Argus II helped them recognize large letters or words, detect street curbs, walk on a sidewalk without falling and match black, gray and white socks.
Retinitis pigmentosa affects about 100,000 people in the United States, according to the University of Southern California. Argus II will be available at the Keck Medical Center of USC in Los Angeles, the university said.
The company is working on getting insurers to cover the system. -- Bloomberg News