The Argus II Retinal Prosthesis System is the first implanted device approved by the FDA to help restore some sense of sight to those over the age of 25 with advanced retinitis pigmentosa (RP).
RP is a rare genetic eye condition where people develop a progressive loss of vision that can result in blindness. About 100,000 Americans have retinitis pigmentosa, according to the New York Times, but only 10,000 to 15,000 people would qualify for the Argus II due to eligibility criteria.
Only those who are over the age of 25 and have a severe form of RP with “bare light or no light perception in both eyes but still have evidence of inner-layer retina function” would qualify reported Medcitynews.com.
The device was approved by the FDA as a humanitarian gesture but it does open the avenue for the future development of other devices that may help treat vision decline from ailments such a macular degeneration.
Humanitarian devices only need to show “probable benefit,” not proof of effectiveness said Dr. Malvina Eydelman, the FDA’s director for the Division of Ophthalmic and Ear, Nose, and Throat Devices. “It’s a big step forward for the whole ophthalmology field.”
“Of the 30 Argus II clinical trial patients, 11 experienced a total of 23 negative effects, the F.D.A. said, including retinal detachment and erosion of the clear covering of the eyeball” reported the New York Times.
The Argus II is the result of 20 years of research by Dr. Mark S. Humayun, an ophthalmologist and biomedical engineer at the University of Southern California and is produced by Second Sight Medical Products. It works by transmitting electric impulses translated by a video processor to the brain.
An “artificial retina” that contains electrodes and a receiver is implanted surgically on the eye. The person wears special eyeglasses that have a small video camera attached to the arm of the glasses.
Video images of what they are looking at are translated into electric impulses that are sent back wirelessly to the surgically implanted receiver on the eye. The impulses are then processed by the implanted electrodes and the remaining retinal cells.