California medical technology maker Second Sight Medical is the 1st to bring a "bionic eye" to the U.S. market, landing FDA approval for the Argus II retinal prosthesis for treatment of blindness.
"This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now," Second Sight president & CEO Dr. Robert Greenberg said in prepared remarks. "With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant."
The device is comprised of 2 main components: an eyeglass-mounted camera and an electrical stimulator implanted in the eye.
"The Argus II System works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina," according to the company. "These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function."
FDA regulators approved Argus II for treating blindness due to late stage retinitis pigmentosa, a condition that leaves patients with either bare light perception or none at all. There is currently no cure for the rare condition, which is diagnosed about 250 times each year.
Some patients with the disease, who were able to unable to see anymore more than extremely bright lights, at best, experienced significant improvements in their vision, researchers said.
"In the patients that have been implanted to date, the improvement in the quality of life has been invaluable," according to University of Southern California’s Dr. Mark Humayun, who spoke on behalf of the company. "The fact that many patients can use the Argus implant in their activities of daily living such as recognizing 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."