Pixium Vision, which is developing bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced updates on its epi-retinal IRIS II system, CE marked for outer retinal degeneration, including retinitis pigmentosa.
• The 6-month followup of clinical safety and performance further demonstrates that IRIS II improves visual performance of the implanted patients and has a favorable safety profile. A full set of interim 6 months results was presented during the 10th International Eye & the Chip Conference in Detroit (USA), 24-26 September 2017,
• A shorter than expected lifespan of the device was noticed in this set of patients. This presents no risk to the implanted patients as the innovative exchangeable design of IRIS II allows for a replacement of the device. A first replacement was already completed successfully during the clinical study. Pixium Vision has nonetheless decided to temporarily halt new implantations in order to validate corrective measures with regulatory bodies, including a revision to the surgical method already identified as a potential solution,
• The first commercial IRIS II implant carried out in Spain was successfully activated recently,
• In France, IRIS II was granted Forfait Innovation by the French Haute Autorité de Santé (HAS) on September 20, 2017.