Second Sight Announces Positive Five-Year Data from Argus II Retinal Prosthesis System
“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”
The paper entitled “Five year safety and performance results from the Argus II Retinal Prosthesis System Clinical Trial” follows the assessment of 30 subjects in the clinical trial (NCT00407602) implanted with the Argus II in 10 centers throughout the United States and Europe.1 All patients were blind (i.e., with bare light perception or worse) from RP or similar disorders. Throughout five years of clinical study, results showed that patients’ visual function improved after implantation with the Argus II and these improvements were sustained over five years. Patients reported that using Argus II had a positive impact on their wellbeing, including a renewed connection with loved ones and the world around them. Results also demonstrated that the Argus II had an acceptable safety profile.
“For patients with RP who are living in darkness, the long-term benefits of the Argus II in restoring some useful vision represents a very meaningful milestone,” said Lyndon da Cruz, MD, PhD, Consultant Retinal Surgeon at Moorfields Eye Hospital NHS Foundation Trust and lead author for the study. “Perhaps most exciting is the proven ability of the Argus II to increase patients’ functional vision. With the Argus II, patients can perform tasks that would not be possible without the device. This can be a life-altering change. It is good that we have now shown that these changes last for many years after implantation.”
“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…….
Read more: http://www.businesswire.com/news/home/20160721006351/en/Sight-Announces-Positive-Five-Year-Data-Argus-II
Source: Business Wire