Second Sight Announces Positive Five-Year Data from Argus II Retinal Prosthesis System - Seite 2

Dr Eman Al Kahtani, MD, Retinal Surgeon and Associate Executive Medical Director of Education, King Khaled Eye Specialist Hospital, Riyadh, said: "At King Khaled Eye Specialist Hospital, we are at the forefront of innovation in ophthalmology and have treated several patients with the Argus II Retinal Prosthesis System, and we see the benefits that patients get from using it in their day to day life. This publication confirms that blind patients can continue to enjoy the benefit of artificial vision five to nine years after surgery, and it increases our confidence and our determination to offer this treatment as an option to alleviate blindness in Saudi Arabia."

"We are excited to see that the substantial visual improvement gained from the Argus II endures over five years - promising news for patients blinded by RP, as well as for our company's continued efforts to restore vision," said Will McGuire, President and CEO of Second Sight. "The study supports the long-term safety profile and benefit of the Argus II system, and these results will continue to drive our approach in the future, both in the development process and in seeking additional regulatory and reimbursement approvals for the Argus II."

In the Argus II study, three types of visual function tests were performed using computer-run assessments: square localization (i.e. object detection), direction of motion (i.e. motion detection) and discrimination of oriented gratings (i.e. visual acuity). Two types of real-world orientation and mobility (O&M) tests were also performed: one test asked patients to locate and touch a door, and the second test asked patients to follow a white line on the floor. The ability to find a door and follow a line have real-world meaning with respect to mobility, ambulation and safety.

Earlier results from this trial were used to gain FDA approval of the Argus II in addition to CE Mark in Europe. The Argus II is the first and only retinal implant to have both approvals, and is the only system to have demonstrated long-term reliability and benefit. Today, nearly 200 patients have been treated with the Argus II.

Positive results of this long-term clinical study follow news about the Argus II's long-term cost effectiveness published in 2014. Researchers evaluated the costs of using the Argus II over 25 years beginning at age 46 (the estimated average age that patients with RP are diagnosed as legally blind) and found that the incremental cost per ratios for the Argus II were about 16,000 US Dollars/quality-adjusted life year - well below payers' cost utility thresholds and costs of "care as usual."^[2],[3]