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Monday, Mar 18, 2024

Turning Eye Toward Future

Second Sight Medical Products Inc. has its eye on a much larger market for its vision-restoring implants, and a new clinical trial could determine whether it will gain access to that market. The Sylmar biotech firm, which has been using its device to restore limited sight to patients who went blind because of a rare disease, on July 22 implanted its product in a patient who suffers from age-related macular degeneration, a much more common cause of blindness. Nearly a month after the implant, the company reported the patient is responding well, and Second Sight is on schedule to implant the device in the remaining four patients who are participating in the European trial by the end of the year. The study could expand the company’s potential customer pool by 2 million patients worldwide. After news of the implant was announced, Second Sight’s stock shot up nearly 7 percent to $14.37, and analyst Amit Dayal with H.C. Wainwright & Co., a research firm in New York, gave the company a “buy” rating and a $21 price target. “I’m incredibly encouraged by the results of our first patient implant,” said Robert Greenberg, company chairman. “We still need to implant in a few more patients, but we look forward to being able to restore central vision lost to those patients who have no therapy available.” Second Sight’s system, often referred to as a bionic eye, features glasses fitted with a miniature camera that sends wireless signals to stimulate a small device implanted on the patients’ optic nerve. Called the Argus II, the system has been implanted in more than 140 patients with retinitis pigmentosa – a rare disease that decreases peripheral and night vision and eventually causes blindness. But until now, it had not been used in patients with the more common macular degeneration. While the glasses send a series of electrical pulses, allowing a patient to perceive patterns of light, the system doesn’t provide detailed vision that would allow reading or many normal activities. Patients can see pixelated images in gray and black, allowing them to make out shapes and figures or distinguish between walls and doors. “This is the first device of its kind to be approved by the (Food and Drug Administration) and is really the first step to try to develop an artificial retina,” said Dr. Abdhish Bhavsar, a retina specialist in Minneapolis and a spokesman for the American Academy of Ophthalmology in San Francisco. “It’s amazing what it can do. And for a person who is completely blind, this is groundbreaking.” Quintupled market At present, the Argus II has FDA approval to treat retinitis pigmentosa, a condition that affects about 375,000 patients worldwide. By contrast, more than five times that number suffer from age-related macular degeneration. The clinical trial in Europe will set the stage for regulatory approval of the Argus II for the macular degeneration market. The study will follow five patients between the ages of 25 and 85 with advanced age-related macular degeneration. Patients will be closely evaluated for three years, and if the study shows good results, the company plans to conduct a larger trial in the United States seeking FDA approval. The Argus II implant and eyeglasses cost roughly $145,000, not including the surgeon and hospital fees for the operation, which can vary by location. There are some private insurers on the East Coast and in the Midwest that are covering all patients who qualify for the surgery; Medicare is accepting patients on a case-by-case basis. Bhavsar said Second Sight might have some difficulty getting insurers on board to cover surgery for macular-degeneration patients in the future. “In the past, macular degeneration has had so many different treatments, (and) we’re talking about treating age-based patients. I don’t think insurers are used to that yet, so it’ll be a new thing for them,” he said. Next technology Greenberg served as Second Sight’s chief executive since the company’s inception in 1998 until last month, when Will McGuire transitioned into the top job. McGuire previously worked at Volcano Corp., a heart imaging company in San Diego that was purchased in February by Royal Philips, a tech company in the Netherlands. Before that, he was chief executive of AtheroMed Inc., a venture capital-backed firm in Menlo Park that develops arterial clearing devices. “I feel fortunate to join the team at Second Sight,” McGuire said. “We have great people, ground-breaking technology and the potential to improve thousands of lives.” Greenberg now serves as chairman – a role billionaire and company founder Alfred Mann previously held. Mann, who as of June owned 33 percent of the company’s stock, is still involved as chairman emeritus. The leadership switch will allow Greenberg to focus on Second Sights’ next-generation products such as the Orion I Visual Cortical Prosthesis – a device that bypasses a patient’s damaged optic nerve and sits directly on the brain. “This is one of the most exciting developments that will allow us to potentially treat up to an additional 6 million patients, or essentially treat all blindness,” Greenberg said. “With many forms of blindness, the optic nerve (which is) the cable going to the back of the brain is damaged, so those patients can’t be helped by putting a device in the eye like we’re currently doing (with the Argus II).” Human trials for the Orion are planned for the first quarter of 2017. For the most recent quarter, Second Sight reported record revenue of $2.7 million, up 335 percent from the same quarter last year. The company had a net loss of $4.9 million, an improvement over the $7.5 million loss in the same quarter the prior year. Shares closed Sept. 2 at $9.17, up from a recent low of $8.82 but well down from its six-month high of $17.44 in early March. In addition to its Sylmar headquarters, the company has a European office in Lausanne, Switzerland, and 29 active implanting centers worldwide. McGuire said the company is looking to open centers and enlarge its footprint in emerging markets. “Outside of R&D, our expansion plans will really be on the commercial side. We’ll be growing our team within new centers and helping train new physicians,” he said. “The majority of the expansion will be within Europe and the U.S.”

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