Sylmar, Calif.-based Second Sight’s Orion is designed to connect the camera in a pair of eyeglasses with an implant that receives the camera signal and translates it to the visual cortex in the brain, bypassing the eye and the optic nerve entirely. The company’s Argus II device, which uses a retinal implant to receive the camera’s signal, is already on the U.S. market.
Interim data from a five-year early feasibility study, presented today at the annual meeting of the Brain Research through Advancing Innovative Neurotechnologies conference in Washington, D.C., involved five patients with bilateral blindness from any cause other than damage to the visual cortex.
The primary safety outcome for the study is the rate of adverse events, with secondary outcomes including phosphene production, long-term device function, benefit to visual function and quality of life. The first subject was implanted in January 2018.
The study showed a significant improvement in the ability to locate a high-contrast target for three of five subjects at six months. Two of the five patients showed significantly better at determining the direction of motion of a high-contrast target. All five patients were rated by certified specialists as having improved functional vision and well-being.
“Observations from rehabilitation sessions include that subjects are able to use Orion to visually detect parked cars, identify the direction of motion of a person walking by, and visually order small objects by size,” Second Sight said.
There was one serious adverse event when a patient had a seizure and four non-serious adverse events, the company said, noting that there were no unanticipated adverse device effects as of Feb. 8.
“We are delighted to share preliminary Orion feasibility study findings with this esteemed group of investigators. This conference provides a forum for discussing exciting advancements and to continue to engage with other scientists who are conducting cutting-edge research in the field,” president & CEO Will McGuire said in prepared remarks. “We are encouraged by the progress Orion subjects are making on visual function endpoints like square localization and direction of motion. With the help of our highly-trained low-vision specialists, our subjects are using Orion at home to perform everyday visual tasks that they cannot do without the system. We look forward to completing the analysis of 12-month data from the Orion Early Feasibility Study and to future refinements that enhance Orion’s ability to provide useful artificial vision to blind individuals.”