The Argus II transmits images wirelessly to a layer of 60 tiny electrodes on the retina inside the eye, to reverse vision lost as a result of retinitis pigmentosa (RP). The product is commercial stage, approved in the United States, Canada, European Union, Turkey, and elsewhere.
RP is a hereditary disease; the Argus II is designed to treat patients who have bare light perception or who are completely blind. The implant is placed during an outpatient procedure; patients wear glasses with embedded video cameras that process data to wireless transmit images to the implant.
Second Sight is running a study in the U.K. on the Argus II and dry age-related macular degeneration, and is beginning pre-clinical studies on a device “that will treat all blindness,” Dr. Greenberg said.
Second Sight has more than 350 patents related to its technology and the implant itself.
The company plans on introducing a new pair of glasses that will be introduced in 2016; improved aesthetics and a 25-fold faster processor “should be able to improve the quality of vision that these patients are seeing,” Dr. Greenberg said. In the clinic, upwards of a “half-dozen patients” in a U.K. study were able to have color vision.
The Food and Drug Administration recently granted the company approval for a new fitting algorithm that will reduce the number of fittings/adjustments from three sessions to one session.
Second Sight has initiated a feasibility pilot study in Manchester, U.K.; at the time of the OIS presentation, three patients had been implanted. Study results are expected in the first half of 2016.
The “Orion” project is using the Argus II device to interface directly with the nervous system, meaning it can bypass the optic nerve and deliver images directly to the visual cortex. If successful, this will represent the first wireless system able to direct images to the visual cortex.
More than 30 patients in the U.S. have received pre-authorization for reimbursement, and there are “more than half a dozen private insurers who cover the procedure as well as Medicare,” Dr. Greenberg said.
There are Medicare codes for both the procedure and device, and three of the eight Medicare contractors have coverage policies in place. The company is still in discussions with CMS over pricing. In Europe, the procedure is covered. Through the first 9 months of 2015, the company generated $6.5 million; Second Sight does not have any outstanding debt.
Robert Greenberg, MD, PhD
Dr. Greenberg currently serves as Chairman of the Board of Second Sight Medical Products. He is a Founder of the company and served as President, CEO and Director from 1998 until August 2015.