FDA last week approved a breakthrough device that uses an artificial retina to restore limited vision to patients blinded by a retinal disease, and experts say the "game changing" technology could have wider uses.
Retinitis pigmentosa—a rare genetic disease that affects about 100,000 U.S. residents—damages light-sensitive cells that line the retina, eventually diminishing a person's ability to discern light from dark until they succumb to total blindness. "It's a horrendous disease," says Robert Greenberg, CEO of Second Sight, the company that spent two decades developing the Argus II device.
The Argus II system includes a surgically implanted retina with about 55 electrodes and a pair of eyeglasses with a small video camera and video processor. Together, the components turn an image into data that is relayed to the brain via the implanted retina.
Currently the device only enables most users to see shades of grey and general outlines or boundaries of shape. (Although the system fits 55 electrodes on a five- by seven-millimeter device, it is no match for the approximately 100 million receptors in a fully seeing eye).
Nonetheless, the device is "a game-changer in a lot of ways," Greenberg told the Washington Post, noting that, "To go from complete darkness to being able to identify letters and words, it’s a pretty significant step."
FDA approved Argus II as a "humanitarian use device" because it will be used on less than 4,000 patients annually. To apply for such approval, Second Sight had to demonstrate "probable benefit" and device safety, but not necessarily effectiveness, FDA's Malvina Eydelman told the New York Times.
Although only about 15,000 U.S. residents may be eligible for the $150,000 device, experts say the technology hold promise for other causes of blindness—including macular degeneration, which affects about two million Americans.
Moreover, researchers say that applying the technology to other conditions—such as implanting electrodes in other parts of the body to address bladder control or spinal paralysis—could open the door to treatments for a wide array of ailments (Belluck, New York Times, 2/14; Dennis/Hun, Washington Post, 2/14; Wang/Jones, Wall Street Journal, 2/14).
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