FDA Approves 'Bionic Eye' for Rare Vision Disorder
A third person said he had a 17-year-old son, "and I don't mind telling you how much -- I mean, how happy that made me, not only to see the silhouette of my son, but to hear that voice coming and saying, 'Yeah, it's me, Dad. I'm here and I love you.'"
People with retinitis pigmentosa suffer damage to the light-sensitive cells of the retina. As these cells slowly degenerate, patients lose side vision and night vision and later on, central vision. The disease can cause blindness,
The FDA's approval is a limited one, labeled a "humanitarian use device" approval, meaning the Argus II can be used only for fewer than 4,000 patients per year.
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.