Only the Argus II system has been cleared for use by the U.S.
The FDA’s Argus II approval drew worldwide media coverage. A number of stories highlighted the case of 61-year-old Kathy Blake, who is Dr. Humayun’s patient and the first RP patient in the US to be implanted with the device. The Argus II restored her sight after having been blind for 23 years. She was featured on NBC Nightly News with Brian Williams1 and on ABC Good Morning America.2
The Argus II consists of several components, as shown in Figures 1-3:
Mark Humayun: It’s possible. The concern is, I think everybody wants to put these implants in; I’ve already had a lot of requests. But as mentioned, initially Argus II will be available at only a limited number of centers of excellence, so it doesn’t make sense to have a big wet lab and have everybody train up on it. For now, I think it’s wiser to focus on the centers that will offer Argus II in 2013 and get them up to speed.
Argus II has been FDA approved as a humanitarian-use device, an approval pathway limited to devices that treat or diagnose fewer than 4000 people in the US each year.
ARGUS II Patient Lisa Kulik Regains Vision
1. da Cruz L, Dorn JD, Humayun MS, et al. Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial. . 2016;123(10):2248-2254.
About the Argus® II Retinal Prosthesis System
Lyndon da Cruz, MA, MD, PhD
• professor of stem cell and retinal transplantation surgery, University College London, and consultant ophthalmic surgeon specializing in medical and surgical retina at Moorfields Eye Hospital, both in London, UK
• financial disclosure: Second Sight provides institutional funding to Moorfields Eye Hospital for the trial of the Argus II retinal prosthesis system; however, the author has no financial interest in the sale of the device.
• +020 7566 2251;
Robert Greenberg, Second Sight’s chief executiveofficer.
New patients continue to be implanted with the Argus II, and more than 150 patients worldwide are using the retinal prosthesis system. Patient-driven data will serve as a critical resource to help scientists understand how the device is used by patients. This knowledge will serve to drive further development and improve upon its limitations.
There are now Argus II enrolling centers in 5 US cities:
The outcomes of the functional tests and safety profile of the Argus II based on earlier results from this clinical trial led to its regulatory approval in the European Union, the United States, and Canada. In many countries, the Argus II is the only available treatment for profound vision loss resulting from RP and outer retinal dystrophy. Year-5 data reinforces the findings of long-term efficacy and safety of this device. The original study patients will continue to be followed and monitored to see what, if any, long-term effect there is on the stimulated nerves and how the device interacts with the human body.
Second Sight Argus® II Retinal Prosthesis System
Five years after implantation, visual function and functional vision, for patients as a group and individually, were better using the Argus II system as compared with their residual vision with the device turned off (Table). Only one new SAE (a rhegmatogenous retinal detachment) occurred between 3 and 5 years after device implantation, and it was treated successfully and resolved. This was reassuring to the investigators, as it showed that the onset of new SAEs was decreasing with time and that, overall, the device remained safe in the long term. The results of the assessment tests at 3 and 5 years are shown in the Table. Improvement was measured against residual vision.