FDA Approves 'Bionic Eye' for Rare Vision Disorder
The FDA is currently restricting approval to people aged 25 years and older who have severe retinitis pigmentosa and can see light but not identify its source. Eligible patients also include those who cannot see light, but who have some retinal function and a history of being able to see forms.
In addition, patients must be willing and able to get the recommended follow-up, device fitting and visual rehabilitation, the agency said.
Dr. Robert Greenberg, president and CEO of Second Sight Medical Products Inc., the maker of the device, said that "patients with retinitis pigmentosa in the United States for the first time ever will [now] have a treatment option."
Greenberg said the device does not restore full vision, but does give patients what he calls "low vision," meaning it lets them perform visual tasks that they couldn't otherwise do.
This is only the first step, Greenberg added. "One of the great things about the Argus II system is that it is a software-driven system," he said, and "we expect to be producing software upgrades for all the implanted patients."
Current lab work suggests those upgrades will include color vision and sharper images, he said. "We are also working on more advanced implants," Greenberg said.
The device is not cheap -- in Europe, where the device has been approved for use for several years, it typically costs about $100,000, with an additional $16,000 for the operation. The company hasn't set a U.S. price yet, but Greenberg say it is going to exceed $100,000.
Insurance typically covers the cost in several European countries, and the company has started a process to get it covered in the United States, Greenberg said.
To gain FDA approval, the system had to go through a clinical trial to see if the device was both safe and effective. The results showed that most participants could perform basic activities better with the device than without.
Activities tested included locating and touching a square on a white field; detecting the direction of a motion; recognizing large letters, words or sentences; detecting street curbs; walking on a sidewalk without stepping off; and matching black, gray and white socks, according to the FDA.
Among the 30 people in the study, 19 had no adverse events related to the implant surgery.
Eleven patients, however, did experience serious problems. These included erosion of the layer covering the eyeball called the conjunctiva, opening of the wound left by the operation, retinal detachment, inflammation and low pressure in their eyeball, the agency noted.
For more information on retinitis pigmentosa, visit the U.S. National Library of Medicine.