World's first approved bionic eye to launch in U.S.

The Argus II, which treats patients with the rare genetic condition known as retinitis pigmentosa, was approved by the FDA in February after more than 20 years in the making.

The system includes an eyeglass-mounted camera and a tiny antenna and electrode array surgically implanted onto the retina. Second Sight

After more than 20 years in the making and FDA approval in February, the Argus II bionic eye is finally here. Well, almost. Developer Second Sight says it has selected clinical centers in 12 U.S. markets where it will begin rolling out the groundbreaking technology later this year.

The Argus II Retinal Prosthesis System, which was approved in February to treat adults 25 and older with severe to profound retinitis pigmentosa, doesn't actually restore vision to these patients, but can allow them to detect light and dark, and thus identify the movement or location of objects.

The system helps patients regain some visual function, but does not actually restore sight. Second Sight

The rare, inherited degenerative disease causes its sufferers to have bare or no light perception in both eyes, though they do have inner layer retinal function and a history of the ability to see forms. It is thought to afflict 100,000 people in the U.S., can result in severe to total vision loss, and has no known cure.

The Argus II works via an array of electrodes implanted onto the retina, which transform images that are transmitted wirelessly from an eyeglass-mounted video camera into electrical impulses that stimulate the retina to produce images. The breakthrough treatment is "remarkable," said Suber S. Huang, director of the University Hospital Eye Institute's Center for Retina and Macular Disease, one of the first centers where the implant will be offered.

"The system offers a profound benefit for people who are blind from RP and who currently have no therapy available to them," Huang said in a news release. "Argus II allows patients to reclaim their independence and improve their lives."

Argus II boasts 20-plus years of research, three clinical trials, and more than $200 million in private and public investment behind it. Still, the system has been categorized by the FDA as a humanitarian use device, meaning there is a "reasonable assurance" that the device is safe and its "probable benefit outweighs the risk of illness or injury."

 

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