Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study
--Second Sight has completed additional device testing and addressed outstanding questions previously requested by the FDA--
Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, today announced that the Company 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 August 28, 2017.
- Published: 02 November 2017
- Written by Editor