With the approval, the Sylmar, Calif.-based company is cleared to enroll up to 5 patients total at the University of California at Los Angeles and Houston’s Baylor College of Medicine.
The company said it has also completed device testing and addressed outstanding questions the FDA requested upon receiving prior conditional approval in August.
“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,” board chair Robert Greenberg said in a press release.
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.
“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,” CEO Will McGuire said in a prepared statement.