California researchers who have been working for two decades to create the world’s first “bionic eye” are one step closer to receiving U.S. approval to market the device, which has the potential to restore sight to the blind.
A panel of federal advisors to the U.S. Food and Drug Administration Contact has unanimously recommended approval of the Argus II Retinal Prosthesis System, made by the Second Sight Medical Products Inc. of Sylmar, Calif.
The Argus II system, which has already been cleared for use in Europe, works by converting video images captured by a mini camera in a patient's glasses into electrical pulses that are transmitted wirelessly to electrodes on the surface of the retina. These pulses stimulate the retina's cells to produce visual patterns of light in the brain that allow blind patients with retinitis pigmentosa (RP) to regain some visual function.
The FDA advisory panel determined last September that the benefits of the device outweigh the risks and urged the agency to give Second Sight the green light to market the Argus II in the U.S., making it the first sight-restoring device available.
"We are very pleased with the panel recommendation … The panel deliberations were well informed and thorough and their decision validated over two decades of work by Second Sight and our collaborators," said Robert Greenberg, M.D., president and CEO of Second Sight. "We would also like to thank all of the people around the world with [RP] who volunteered to participate in our clinical trials, and the doctors who treated them. Without their pioneering efforts, today's result would not have been possible."
The first patient received a Second Sight “bionic eye” — the Argus I — about 10 years ago and the company has been testing its newest device in a small number of patients in a clinical trial that began in 2007. The company estimates about $200 million of public and private funds have gone into developing the Argus system.
Other researchers at the Massachusetts Institute of Technology, Stanford University, and other institutions have been working to develop new technologies to restore sight to the blind. But the Argus II system appears poised to be the first to clear regulatory hurdles to becoming widely available in the U.S.
Lyndon da Cruz, M.D., a consultant with Moorfields Eye Hospital in London who recommended the Argus II systems approval to the FDA panel, said clinical trials involving seven British patients who used the system demonstrated its enormous potential to help blind patients.
"While the European Approval [in 2011] was based on the safety and the long-term performance of the Argus II Retinal Prosthesis System, the FDA panel required the demonstration of probable benefit as well,” said Dr. Cruz. “This [FDA advisory panel] recommendation will now give us the chance to improve the quality of life of thousands of blind patients who have absolutely no other treatment options.
"We can now begin to see great hope in the future development of this field and the promise of restoration of sight for those who need it most".
Paulo Stanga, an eye surgeon at Manchester Royal Eye Hospital, who tested the Argus II in three patients also said it produced “tremendous results” and demonstrated that “patients blinded by [RP] could consistently perceive different colors … using Argus II. This data is very encouraging because it suggests the possibility that Argus II with its software capability could be upgraded to one day restore color vision for these blind patients."
RP is an inherited retinal degenerative disease that often results in nearly complete blindness. It affects about 100,000 Americans and hundreds of thousands more worldwide.
Second Sight was founded in 1998 to create a device to provide sight to patients blinded from eye diseases, such as RP. Experts say the Argus II may also prove beneficial to people with other vision problems, such as macular degeneration.
Stephen Rose, M.D., chief research officer for Foundation Fighting Blindness, called the development of the Argus II system is an “exciting and historic moment for people with advanced inherited retinal degenerations such as retinitis pigmentosa."
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