The conditional approval gives the Sylmar, Calif.-based company clearance to enroll up to 5 patients at 2 US sites, but requires that the company conduct additional device testing and “address outstanding questions” within 45 days, it said.
“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. Once we complete those steps, our designated U.S. clinical trial sites, the University of California at Los Angeles and Baylor College of Medicine 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,” prez & CEO Will McGuire said in a prepared statement.
The Orion cortical visual prosthesis system is designed to convert images captured by a miniature video camera, mounted on a patient’s glasses, into a series of electrical pulses which are transmitted wirelessly to an array of electrodes on the surface of the individual’s visual cortex.
The result is the perception of patterns of light, Second Sight said, which bypass the retina and optic nerve to potentially restore useful vision to patients who are completely blind due to reasons including glaucoma, diabetic retinopathy, cancer or trauma.
“The ability to implant the 1st 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,” board chair Dr. Robert Greenberg said in a press release.
In July, Second Sight said it entered the Russian market, with the 1st patient treated with its Argus II Retinal Prosthesis System in Moscow.