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

Source: Second Sight Medical Products

Second Sight Medical Products announced that the company has received full approval from the 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 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 August 28, 2017.

“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,” Robert Greenberg, Chairman of Second Sight, said in a company news release. “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 Chief Executive Officer of Second Sight.

Blind patients interested in the Orion clinical trial can contact Second Sight customer service at 1-855-756-3703 for further information or referral to one of our clinical trial sites.

About the Orion Visual Cortical Prosthesis System

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.

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