Second Sight Medical Products announced it will unveil 5-year outcomes associated with the Argus II Retinal Prosthesis System during the 39th Annual Macula Society Meeting, being held February 24-27, 2016, at Eden Roc Miami Beach. James Handa, MD, the Robert Bond Welch Professor of Ophthalmology at the Johns Hopkins University Wilmer Eye Institute, will present the data for the first time during a session on Inherited Retinal Degeneration on Wednesday, February 24th at 6:12 pm Eastern Time.
Dr. Handa will present long-term results from an ongoing clinical trial (NCT00407602) assessing 30 individuals from 10 clinical centers blinded (i.e., with bare light perception or worse) from retinitis pigmentosa (RP) or similar disorders who were implanted with the Argus II. The data will represent over 200 cumulative patient-years of clinical trial follow-up and will demonstrate the ability for the retinal prosthesis to improve visual function over an extended duration.
“The release of this data represents a milestone in the fight against blindness, given the long-term benefits of the Argus II in restoring some useful vision to individuals blinded by RP. The extended follow-up data clearly demonstrate the utility of the Argus II system, and we have gained considerable knowledge about how best to utilize the device through this trial,” said Dr. Handa.
“We are excited about what this long-term follow up represents, both for patients and for our continued development efforts,” said Dr. Robert Greenberg, Chairman of Second Sight. “These data are compelling in demonstrating the validity of our approach and the reliability of our implants.”
One- and 3-year data from the trial were previously published in the peer-reviewed journal Ophthalmology. For the 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: a test where patients were asked to locate and touch a door, and a test where patients were asked to follow a white line on the floor. The Functional Low-Vision Observer Rated Assessment (FLORA), a multi-part instrument that was developed specifically for use in patients implanted with a retinal prosthesis who suffer from profound loss of vision or blindness, was used to assess the functional visual abilities of patients and how they use the Argus II to complete a series of common activities of daily living. Before the development of the FLORA, there were no accepted, standardized assessments of functional vision or quality of life that could be used to assess the kind of vision that is restored by a retinal prosthesis. Common assessment tools of functional vision that are available such as the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) or the Massof Activity Inventory have only a few items that can be completed by those with ultra-low vision, with the majority of test items requiring higher levels of spatial vision (ability to read, recognize faces, identify colors).
Earlier results from this trial were used to gain approval of the Argus II by the FDA in addition to CE Mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. Although there are several research efforts in retinal prostheses worldwide, none has demonstrated the same level of reliability and efficacy as the Argus II did in a multi-centered, long-term, controlled clinical trial involving 30 subjects. Today over 180 patients have been treated with the Argus II.
Current research efforts by Second Sight include a feasibility study of the Argus II for individuals with dry age-related macular degeneration; hardware and software upgrades for existing and future Argus II patients; and the development of a prosthesis for the primary visual cortex, the Orion I Visual Cortical Prosthesis, suitable for patients with other forms of blindness.