Second Sight Receives FDA Approval to Begin First Orion Human Clinical Study

Second Sight Medical Products Inc., a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, has received full approval from the U.S. Food and Drug Administration (FDA) to begin the Orion Cortical Visual Prosthesis System (Orion) feasibility clinical study. The approval allows two U.S. sites, the University of California at Los Angeles (UCLA) and Baylor College of Medicine (Baylor) in Houston, to enroll up to five total patients. Second Sight has also completed the additional device testing and addressed the remaining outstanding questions requested by the FDA in their prior conditional approval announced by the company on Aug. 28.
 
“We are grateful for the rapid and thorough review by the FDA and are pleased to be able to commence the Orion feasibility study. We look forward to working with the teams at UCLA and Baylor to complete the final steps to begin patient recruitment,” said Robert Greenberg, chairman of Second Sight.

“We remain on track toward achieving our stated goal of implanting our first Orion patient before year end, and the potential opportunity to provide useful vision to millions of blind individuals worldwide who have no other option today, stated Will McGuire, president and CEO of Second Sight.
 
Second Sight, the manufacturer of the Argus II Retinal Prosthesis System (Argus II), has developed a new device, the Orion. A proof-of-concept clinical trial at UCLA demonstrating the viability of stimulation of the human visual cortex with a commercially available device from a different manufacturer was announced in Q4 2016. First-in-human clinical studies with the Orion are planned to begin in 2017.
 
Like the Argus II, the idea behind Second Sight’s Orion is to convert images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses. The Orion is designed to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the perception of patterns of light. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore useful vision to patients completely blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma—many fold more patients than for the current Argus II indications. No clinical data is yet available for the Orion.
 
Second Sight’s Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina’s remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval, and is offered at approved centers in Canada, France, Germany, Italy, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States.
 
Second Sight’s mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and now manufactures and markets, the Argus II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with dry age-related macular degeneration. New hardware and software to improve the quality of the vision produced is underway. A clinical trial to study the Argus II in better-sighted subjects earlier in the disease was recently approved in Germany. Second Sight is also developing the Orion Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. U.S. headquarters are in Sylmar, Calif., and European headquarters are in Lausanne, Switzerland.