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Pixium Vision announces implantation of first patient in Italy in Prima System European pivotal trial PRIMAvera

• First patient treated at PRIMAvera clinical site in Rome, Italy

• Follows successful implantations at clinical sites in France, Germany, the UK and the Netherlands

• PRIMAvera on track to read-out around the end of 2023
  
  

Paris, France, September 13, 2022 – 07:00 CET – Pixium Vision SA (Euronext Growth Paris - FR0011950641; Mnemo: ALPIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces today the successful first implantation of a patient in Italy in the PRIMAvera pivotal trial in atrophic dry age-related macular degeneration (dry AMD).

This follows the approval of the PRIMAvera study by the Italian Ministry of Health and the opening of the first clinical site in Italy at the Complesso Ospedaliero San Giovanni Addolorata. The PRIMAvera study aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe. The study was initiated in Q4 2020 in France. Pixium Vision has since established additional clinical sites and implanted patients in Germany, the UK and the Netherlands.

"We are very pleased to have successfully implanted the first patient in Italy with the Prima System as part of the expanding PRIMAvera pivotal study," said Prof. Andrea Cusumano, co-investigator of the PRIMAvera study for Italy. "We have been following the development of the Prima System since its inception and we have seen the significant promise it shows for those suffering from dry AMD, a disease for which we struggle to provide acceptable solution and hope to patients and their families. PRIMA's small size and wireless design means the implantation is a straightforward procedure which can be completed with minimal surgery. We will move ahead now with further implantations and we look forward to adding our efforts to the clinical assessment of this innovative technology."

The PRIMAvera study design is based on the positive data generated in a French feasibility study, showing the ability of patients with dry AMD to improve visual acuity with the Prima System.

A total of 38 patients will be implanted in the PRIMAvera study, an open-label, baseline-controlled, non-randomized, multi-center, prospective, single-arm pivotal trial. The primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months, and the primary safety endpoint is the number and severity of device and procedure-related serious adverse events at 12 months follow-up. The study will include three years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.