FDA approves device to give blind partial vision

Published: Monday, Feb. 18 2013 7:00 a.m. MST

In this photo taken Saturday, Feb. 12, 2011,Eric Selby poses for a photograph with a "sight" camera fitted in a pair of glasses, which works in conjunction with an artificial retina implant called the Argus II fitted in his right eye, enabling him to detect light, in Coventry, England. For two decades, Eric Selby, 68, had been completely blind and dependent on a guide dog to get around. But after having an artificial retina put into his right eye, he can detect ordinary things like the curb and pavement when he's walking outside.

Martin Cleaver, AP

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The U.S. Food and Drug Administration has approved use of the "artificial retina" so that some people who are blind will gain limited vision. It's the first treatment of its kind to help those who are blind.

The National Science Foundation called the Argus II the "first bionic eye" approved for patients in the United States, the technology developed with support from government and other agencies, including NSF.

According to an article in the New York Times, it is expected to allow those with a certain type of blindness, retinitis pigmentosa, to "detect crosswalks on the street, the presence of cars and sometimes even large numbers or letters."

"This is just the beginning," Grace Shen, director of the retinal diseases program at the National Eye Institute, which helped support this and other therapy projects, told the New York Times. "We have a lot of exciting things sitting in the wings."

An individual dons a pair of eyeglasses that carries a small camera that's hooked wirelessly to a microelectrode array implanted on a patient's damaged retina. It sends signals through the optic nerve to the brain, which interprets a visual image.

"The implant allows some individuals with RP, who are completely blind, to locate objects, detect movement, improve orientation and mobility skills and discern shapes such as large letters," the foundation said in a statement announcing the approval.

Retinitis pigmentosa, often referred to simply as RP, is an eye disease in which the layer of tissue at the back of the inner eye, the retina, is damaged. That is the part of the eye that converts light images into nerve signals before sending them to the brain for translation.

Argus II is made by Second Sight Medical Products, of Sylmar, Calif. It is part of the development team that has spent nearly 20 years developing the system, using both private and public investment.

"Seeing my grandmother go blind motivated me to pursue ophthalmology and biomedical engineering to develop a treatment for patients for whom there was no foreseeable cure," the technology's co-developer, Mark Humayun, associate director of research at the Doheny Eye Institute at the University of Southern California and director of the NSF Engineering Research Center for Biomimetic MicroElectronic Systems (BMES), said in a statement. "It was an interdisciplinary approach grounded in biomedical engineering that has allowed us to develop the Argus II, making it the first commercially approved retinal implant in the world to restore sight to some blind patients."

The NSF release noted that the researchers bridged cellular biology, "necessary for understanding how to stimulate the retinal ganglion cells without permanent damage," using microelectronics.

About 50 patients in the United States and Europe have been testing the device in clinical trials. One, Elias Konstantopolous, 74, a retired electrician from Baltimore, told the Times that "when you have nothing, this is something. It's a lot." Some of the trial participants reported seeing some color, though not all of them did.

As many as 100,000 Americans have RP, but between 10 and 15 percent will initially qualify for the technology. Requirements at first will include being over 25, having at one time had useful vision that has diminished to the point the device's limitations would still be an improvement.

The initial cost is expected to be around $150,000, not counting surgery and training. The company told CBS News that at some point insurance companies are likely to cover it, though not yet.

EMAIL: lois@desnews.com, Twitter: Loisco

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