Visual Prosthesis Market Differentiates as it Expands
by James Cavuoto, editor
January 2019 issue
Vendors of visual prosthetic systems have expanded their product offerings and also their target market in recent months as the emerging industry continues to expand. Both Second Sight and Pixium Vision announced significant commercial and clinical progress at the Digital Medicine and Medtech Showcase in San Francisco, CA earlier this month.
Second Sight CEO Will McGuire provided preliminary results from the first five patients in a feasibility study of the company’s Orion cortical stimulation system. He said that four of the five were cleared for home use and that they could identify sidewalk edges and other navigation cues. The device offers them a 40-degree field of view, he said.
Although the company is still doing well with its Argus II retinal implant for users with retinitis pigmentosa—they’re selling about 70 devices per year and CMS has upped its repayment rate to $152,200 for 2019—management is clearly pinning its hopes on Orion. The device is targeted at people with glaucoma, diabetic retinopathy, eye trauma, and optic nerve disorders, representing an addressable market of 70,000 in the U.S., compared to 1500 with Argus II. In an interview with NBR, McGuire said that future generations of the Argus platform would stress advances in image processing such as facial recognition or depth-based decluttering, rather than electrode density, which will like stay capped at 60. The Orion platform, now at 60 electrodes, could reach 150 to 200 contacts, he said.
While Second Sight has positioned itself as the market leader for treating individuals with total blindness, Pixium Vision has elected to prioritize the market for advanced dry AMD, for which there is little to no therapeutic options presently. CEO Khalid Ishaque reported that its subretinal PRIMA system met the endpoints of a feasibility study in France, at interim six months follow-up. “These results exceeded our initial expectations,” he said. “For patients who had completely lost their central vision, PRIMA enabled the majority of them to begin to correctly identify patterns and letters.” Pixium is currently recruiting patients for a feasibility study in the U.S. and is preparing for a pivotal study and subsequent CE Mark in Europe.
The interim clinical results with PRIMA, a wireless photovoltaic microchip, show that it can be safely implanted under the atrophic macula while preserving the residual natural peripheral visual acuity. The trial showed successful elicitation of light perception in the central retinal area in all subjects who had no remaining central visual activity.
The company reported that the implant is well tolerated, with no device-related serious adverse events. Also, the implant does not move after natural retina healing and remained stable in all patients.
The PRIMA device is a photovoltaic chip containing 378 electrodes. Its size is 2 mm by 2 mm and 30 microns thick. Implanted under the retina via a minimally invasive surgical procedure, it acts like an array of tiny solar panel powered by pulsed near infrared light projected from a miniature projector integrated into augmented reality glasses, along with a mini-camera.Tweet