New results with the Argus II Retinal Prosthesis System in retinitis pigmentosa- Second Sight Medical

Second Sight Medical announced positive three year results post-implant of its Argus II Retinal Prosthesis System from a multi-center clinical trial. The results, published in a paper titled, �Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind�, highlights 30 subjects implanted with the Argus II at 10 centers throughout the United States and Europe. Of the 30 subjects tested, 29 remained implanted with functioning Argus II systems at three years post-implant.

Results showed that with the Argus II System, improvements in visual function and O&M were maintained out to three years. Up to 89 percent of subjects performed statistically better with the Argus II system implanted compared with native residual vision in visual function tasks at year three. During the trial, the FLORA also demonstrated that up to 80 percent of the subjects received benefit from the system when considering both functional vision and patient-reported quality of life, and no subjects were affected negatively. The results of the trial support the long-term safety profile and benefit of the Argus II for individuals who are blind due to retinitis pigmentosa.

Comment: 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 have demonstrated the reliability and efficacy of such a device in a multi-centered, long-term, controlled clinical trial involving 30 subjects, as was demonstrated by the Argus II in this study.