FDA: Retinal Implant Approved for Inherited Eye Disease
(HealthDay News) – The Argus II Retinal Prosthesis System has been approved by the U.S. Food and Drug Administration to treat adults with advanced retinitis pigmentosa (RP), a rare genetic disease that damages light-sensitive cells that line the eye's retina.
This first-approved implant includes a tiny video camera, a transmitter mounted on a pair of glasses, and an implanted artificial retina that helps the brain perceive images and movement, the FDA said in a news release.
The new system is intended for people aged >25 years who have severe RP that restricts their perception of light, vision, and movement. The device will not restore full vision but will aid in the detection of light and dark and the ability to identify the location and movement of people and objects, the FDA said.
In clinical testing, the device helped people detect motion, recognize large letters and words, detect street curbs, helped in the ability to walk along a sidewalk without stepping off, and helped in selecting matching socks.
Adverse reactions observed during the study included erosion of the eye's conjunctiva, opening of the wound along a surgical suture, retinal detachment, and inflammation.
The device's development was funded by several U.S. government agencies and by Second Sight Medical Products, based in Sylmar, CA.