Second Sight Medical Products Inc (NASDAQ: EYES) shares rose Monday, after the company disclosed that it has received a conditional Food and Drug Administration approval to start the first Orion human clinical study.
The Sylmar, California-based company is a developer, manufacturer and marketer of implantable visual prosthetics to provide useful vision to blind patients. The conditional approval allows two U.S. sites to enroll up to five 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.
According to Second Sight CEO Will McGuire, “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.
Second Sight, maker 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 for before the year is out.
Company stock gained 13 cents, or 13%, as the clock approached noon ET Monday, to $1.13.
