Medical Device Daily Senior Staff Writer
An FDA ophthalmic devices advisory panel recommended approval of the Argus II retinal prosthesis system in a unanimous vote Friday. The panel spent 10 hours reviewing and discussing data submitted from an international clinical trial of the retinal implant, made by Second Sight Medical Products (Sylmar, California), that is designed to partially restore vision to patients who are blind due to retinitis pigmentosa (RP).
"I am very pleased with the panel recommendation today. 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, MD, PhD, president/CEO of Second Sight. "I 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 panel, which was comprised of 19 voting members (23 members total) with expertise in ophthalmology, retinal disease, low vision, electrophysiology and other specialties heard testimony from the sponsor, FDA, and several doctors and participants involved in the most recent clinical trial that began in 2007. After hearing the testimony, asking questions, discussing concerns, and deliberating, the panel voted 19-0 that the probable benefit of the Argus II retinal prosthesis system outweighs the risks to health.
"We are looking forward to working with the FDA now to quickly get the product approved," said Anne-Marie Ripley, VP of clinical and regulatory affairs at Second Sight. "There is no therapy available currently for these patients and we would like to make Argus II available to American doctors and their patients as soon as possible."
Earlier this year Second Sight reported successful interim results from its single arm, controlled, prospective multicenter clinical trial of the device (Medical Device Daily, Feb. 9, 2012).
The company noted that the recommendation comes after more than 20 years of work in the field, three clinical trials, more than $100 million in public investment by the National Eye Institute (NEI; Bethesda, Maryland), the Department of Energy (Washington), and the National Science Foundation (Arlington, Virginia), and an additional $100 million in private investment.
"This is a truly exciting and historic moment for people with advanced inherited retinal degenerations such as retinitis pigmentosa," said Stephen Rose, PhD, chief research officer at the Foundation Fighting Blindness (Columbia, Maryland), which helped get the project started with early support. "The Argus II has the potential to provide life-changing vision capabilities, and we are delighted to see the prosthesis make a big step toward FDA approval and getting out to the people with severe vision loss who can benefit from it."
RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 100,000 Americans and has been designated by the World Health Organization as an orphan disease. In 2009, the Argus II, which is intended to help the worst affected RP patients, received a humanitarian use designation, making it a candidate for an HDE approval which is intended to expediate the market introduction of technologies intended to treat smaller, underserved patient populations.
According to Second Sight, 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. These pulses are intended to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns thereby regaining some visual function. Second Sight gained European approval, the CE mark, for the system in 2011, marking the first approval of a retinal prosthesis anywhere in the world (MDD, March 4, 2011).
The company also just so happened to win a unique honor last year of receiving the eight millionth patent issued by the U.S. Patent and Trademark Office for a patent protecting the Argus II (MDD, Sept. 8, 2011).
"Modest gains in vision can make a big difference to a person blinded by retinitis pigmentosa," said Paul Sieving, director of the NEI. "The Argus II retinal prosthesis allows users to reclaim their independence and improve their lives. The NEI is proud to have provided support to Second Sight to make the Argus II a reality."
As of press time Monday, attempts to reach Second Sight for additional comment regarding the panel recommendation were not successful.
If approved by the FDA, the Argus II would also be the first approved retinal prosthesis in the U.S.
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