WASHINGTON — 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.
The Food and Drug Administration cleared the Argus II Retinal Prosthesis System from closely held Sylmar, Calif.- based Second Sight Medical Products Inc. to replace the function of degenerated cells in the retina, the agency said Thursday in a statement. The system helps adult patients with advanced retinitis pigmentosa, which damages light-sensitive cells that line the retina located at the back of the eye, causing a gradual loss of vision that may lead to blindness.
The device consists of a video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and an implanted retinal prosthesis. The processing unit transforms images into electronic data that is transmitted to the artificial retina, the FDA said.
"This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now," Robert Greenberg, president and chief executive officer of Second Sight, said in a statement.
The system won't restore sight. It gives patients the ability to perceive the difference between light and dark, the FDA said. A clinical study of 30 people showed the Argus helped patients recognize large letters or words, detect street curbs, walk on a sidewalk without falling and match black, gray and white socks.
Of the 30 patients in the study who were followed for two years, 19 experienced no side effects, while others experienced adverse events such as retina detachment, surgical wounds that split open and erosion of the clear covering of their eyeballs.
The Department of Energy, the National Eye Institute of the National Institutes of Health and the National Science Foundation collaborated to provide $100 million to support the development of the Argus system, the FDA said.
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