At the ASRS 31st Annual Meeting, Mark S. Humayun, MD, PhD, presented updated safety and performance results of the Argus® II Retinal Prosthesis System clinical trial and gave an overview of the commercial experience in Europe.
As of December 1, 2012, 30 subjects have been implanted at centers in the main study. This is the largest study of a visual prosthesis to date, with more than 125 cumulative patient-years of follow-up.
Results show the Argus II prosthesis provides visual function to patients with end-stage retinitis pigmentosa. Research has demonstrated visual acuity as high as 1.0 logMAR (20/200) and color perception. A total of 54 clinical trial subjects and commercial patients worldwide have received the Argus II implant.
The Argus II Retinal Prosthesis System has been commercially available in Europe since 2011 and received US Food and Drug Administration (FDA) approval in February 2013. As of October 1, 2013, the Argus II system has been approved for Medicare coverage. Software upgrades may extend the Argus II’s capabilities.
Following his presentation, Dr. Humayun sat down with Retina Times Editor-in-Chief J. Michael Jumper, MD, to discuss the Argus II system.
Dr. Humayun – SECOND SIGHT MEDICAL PRODUCTS, INC: Advisory Board, Consultant, Investigator, Stockholder, Grants, Intellectual Property Rights, Royalty, Salary, Stock, Stock Options.
Dr. Jumper – COVALENT MEDICAL, INC: Founder, Royalty; DUTCH OPHTHALMIC USA: Speaker, Honoraria; GENENTECH: Investigator, No Compensation Received; OPTOVUE INC: Investigator, Equipment (Department or Practice); THROMBOGENICS, INC: Investigator, No Compensation Received.