Second Sight Medical Products announced its plan to accelerate the development and commercialization of its Orion Visual Cortical Prosthesis System. Orion holds the potential to provide useful artificial vision to individuals blind from many causes, including glaucoma, eye injury, diabetic retinopathy, optic nerve disease or injury, and retinitis pigmentosa.
“Given the positive results of our early feasibility study, we believe that Orion offers the most effective and quickest path forward to treat nearly all forms of blindness and address a significant unmet need,” Will McGuire, President and Chief Executive Officer of Second Sight, said in a company news release. “After an extensive strategic review, we view Orion as a more attractive platform for continued investment and technological improvement that will extend our leadership position in artificial vision. We remain encouraged by our discussions with the U.S. Food and Drug Administration (“FDA”) regarding Orion’s regulatory path and are pleased by recent developments with the Centers for Medicare and Medicaid Services (CMS) regarding reimbursement for products approved via the FDA’s Breakthrough Devices program.”
“To support these initiatives, we intend to add more than 25 new positions this year, including top research and development talent as we pursue technological improvements of Orion. We are also taking steps to further align our organizational capabilities and focus resources primarily on advancing Orion as well as prepare for future sales volumes that we expect to be orders of magnitude greater than Argus II. Accordingly, we will suspend production of new Argus II systems in the near future as well as reduce ongoing commercial activities,” Mr. McGuire said.
The Orion Visual Cortical Prosthesis System is an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. A six-subject early feasibility study of the Orion is currently underway at the Ronald Reagan UCLA Medical Center in Los Angeles and the Baylor College of Medicine in Houston. No peer-reviewed data is available yet for the Orion system. The Company anticipates enrolling additional feasibility subjects in 2019 while simultaneously negotiating the clinical and regulatory pathway to commercialization with the FDA as part of the Breakthrough Devices Program.
“We remain committed to supporting existing Argus II users including pursuing regulatory approvals for the Argus 2s next-generation externals. Our commitment to artificial vision is further evidenced by our continued investment in multiple research projects designed to enhance the user experience, such as the integration of object or facial recognition and thermal imaging, with our technology,” Mr. McGuire added.
Gregg Williams, Chairman of the Board, said, “Orion provides a tremendous opportunity to further advance the field of artificial vision while also addressing the needs of millions of blind individuals globally. With encouraging early clinical results, we believe now is the right time for the Company to transition to the Orion platform and focus on accelerating our development and clinical programs. Second Sight will continue providing support to existing Argus users worldwide while repositioning our resources to accelerate the market introduction of Orion.”