“For someone who can’t see, it’s a life changer to suddenly be able to walk into a room and see where the door is,” said Brian Mansfield, deputy chief research officer at the Foundation Fighting Blindness, which describes itself as the largest private organization funding such research.
The approval marks a milestone in the research of retinal diseases, which affect millions of Americans. A growing number of potential treatments for the ailments include stem cells, gene therapy, pharmaceuticals and surgical procedures.
The device, which received approval from European regulators in 2011 and has been implanted in more than 50 patients overseas, is designed for adults with advanced retinitis pigmentosa, a rare genetic condition that in the United States affects about 100,000 people. The condition damages the light-sensitive cells that line the retina. In time, a person’s limited ability to tell light from dark can erode, and often the outcome is total blindness.
“It’s a horrendous disease,” said Robert Greenberg, chief executive of Second Sight, the California-based company that has been developing the Argus II retinal prosthesis for two decades. “Their visual world closes in on them gradually until they are completely blind.”
The Argus II system approved Thursday includes a surgically implanted artificial retina about the size of an aspirin and with about 55 electrodes. Patients then are outfitted with a pair of eyeglasses with a small video camera and video processor. Together, the components transform images from the video camera into data that is transmitted to the brain through the implanted retina.
“It’s a game-changer in a lot of ways,” Greenberg said. “To go from complete darkness to being able to identify letters and words, it’s a pretty significant step.”
Currently, the technology allows patients only to see shades of gray. Greenberg said his company is developing artificial retinas that will provide both higher-resolution and color images and ones to help a wider array of patients with little or no vision.
Thursday’s news drew a jubilant reaction from patients who stand to benefit from the technology, either now or in the future.
“I think this could lead, in a very few years, to a fundamental revolution that will end many forms of blindness as a disability,” said Karen Shaw Petrou, 59, a Washington banking consultant who has a type of retinal degenerative disease and relies on a guide dog to navigate the city.
Petrou still has some sight and isn’t eligible yet to have the new implant in her eye, but like others, she hopes that she could benefit if the FDA approves wider use of the device.