The FDA has granted Second Sight Medical an Expedited Access Pathway designation for its new visual prosthesis system designed to restore sight to patients who are completely blind.
The news comes a week after the Sylmar, California-based company received full FDA approval to begin testing the Orion Cortical Visual Prosthesis System in humans. With the EAP designation, the device will enjoy an expedited review process.
“These advantages potentially allow the FDA to approve Orion with fewer patients and with a shorter follow-up timeline, thus facilitating a faster entry of Orion into the commercial market. We are delighted about the opportunity for patients to have expedited access to Orion, once approved,” said Second Sight CEO Will McGuire.
Second Sight already markets its Argus II Retinal Prosthesis System in a number of countries. The FDA approved it for humanitarian use in 2013, a classification for devices that treat rare diseases.
The Argus II uses a miniature video camera mounted on a pair of glasses to capture images, which are sent to a small patient-worn computer. The images are then processed and converted into instructions that are sent wirelessly to an implant in the retina, which induces visual perception, the company says.
Like the Argus II, the Orion system uses a miniature camera to capture images, which are then turned into electrical impulses. The Orion system is designed to transmit these impulses wirelessly to electrodes implanted on the surface of the brain’s visual cortex.
“FDA’s Expedited Access Pathway is a game changer for nearly all blind individuals in the U.S. who currently have no treatment options,” said Robert Greenberg, Second Sight chairman, in the statement. “We look forward to moving the program ahead and working with the FDA in the coming months to map out the most efficient path to market for this therapy, which has the potential to treat most causes of blindness.”
