Second Sight Medical Products announced that it has received conditional approval from the FDA to begin the Orion Cortical Visual Prosthesis System feasibility clinical study. The conditional approval allows two US sites to enroll up to five total patients. The FDA has also requested that the company conduct additional device testing and address outstanding questions. Second Sight has 45 days to respond to FDA’s requests.
"This is an exciting milestone for the company given the potential of Orion to provide useful vision to millions of blind individuals worldwide who have no other option today. We are delighted to have received conditional approval from the FDA to move forward and can now focus on finalizing the various approvals and agreements required at each clinical trial site," Will McGuire, President and Chief Executive Officer of Second Sight, said in a company news release. Once we complete those steps, our designated U.S. clinical trial sites, the University of California at Los Angeles (UCLA) and Baylor College of Medicine (Baylor) in Houston, can begin patient recruitment efforts. The Orion team has met all major internal milestones this year and we remain on-track to achieve the Company’s stated goal of implanting our first Orion patient before year end,”
“The ability to implant the first Orion system, which has the potential to treat nearly all forms of profound blindness, has been a stated goal of the company since our IPO. We are grateful for the rapid review and approval by the FDA. This milestone is a testament to the careful, high-quality work completed by the Second Sight and UCLA teams to date. We look forward to continuing our work with UCLA as this exciting clinical trial begins and also welcome Baylor to this important effort,” stated Dr. Robert Greenberg, Chairman of the Board.
Blind patients interested in the Orion clinical trial can contact Second Sight customer service at 1-855-756-3703.
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 demonstrating the viability of stimulation of the human visual cortex with a commercially available device from a different manufacturer began in Q4 2016 at UCLA. First-in-human clinical studies with the Orion are planned 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.