The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited access pathway, giving Sylmar, Calif.-based Second Sight priority review, greater interactive review for both its investigational device exemption and pre-market approval bids, plus more emphasis on post-market studies rather than pre-market clinical work. The FDA will also assign a cross-disciplinary case manager for the Orion review.
“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,” president & CEO Will McGuire said in prepared remarks.
“FDA’s expedited access pathway is a game-changer for nearly all blind individuals in the U.S. who currently have no treatment options. 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,” added chairman and co-founder Dr. Robert Greenberg.
Second Sight’s first-generation device, the Argus II, won FDA approval in February 2013. That system uses an eyeglass-mounted camera and a retinal implant.
Earlier this month Second Sight won FDA approval to launch a feasibility study for Orion, which is designed to bypass the retina and optic nerve altogether to deliver visual stimulus directly to the visual cortex.