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February 14, 2013 11:29 pm
Millions of blind people will be able to regain limited sight after the world’s first “bionic eye” was approved by US regulators.
The US Food and Drug Administration has approved a retina implant that will help address retinitis pigmentosa, a rare genetic eye disease, but will not cure all types of blindness.
Created by Second Sight, the device uses a prosthetic retina, which replaces degenerated cells in the eye, to receive signals from a small video camera and transmitter that is mounted on a pair of glasses. The device, known as the Argus II, allows a blind person to detect shapes and movement.
“This new surgically implanted assistive device provides an option for patients who have lost their sight to RP – for whom there have been no FDA-approved treatments,” said Dr Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The device may help adults with RP who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities.”
The device was approved in Europe last year and is expected to become available in the US later this year.
“The fact that many patients can use the Argus implant in their activities of daily living such as recognising large letters, locating the position of objects, and more, has been beyond our wildest dreams, yet the promise to the patients is real and we expect it only to improve over time,” said Dr Mark Humayun, professor at the Doheny Eye Institute at University of Southern California.
The Argus device only works for people who have lost vision due to degeneration of photoreceptor cells in the retina, not people who have lost vision because of problems with their optic nerves.
Clinical studies found that blind people using the Argus could recognise large letters and words, detect street curbs and match grey, black and white socks.
The FDA approval follows 20 years of research and more than $200m of investment, according to Second Sight.
The company did not reveal the cost of the device, but Dr Humayun said in 2007 that it could cost around $30,000 for an implant.
Retinitis pigmentosa affects about 100,000 people in the US and more than 1m around the world, according to the Digital Journal of Ophthalmology.
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