Pixium Vision announced reaching his enrollment target in the European approval study PRIMAvera and Iimplantations planned to complete through end of 2022

• The target number of 38 patients was enrolled at clinical sites in France, Germany, UK, the Netherlands and Italy
• Waitlist initiated for additional patients to replace potential pre-implant dropouts and ineligibility
• Implantations to be completed by the end of 2022; PRIMAvera reading expected at the end of 2023

Paris, France, September 19, 2022 – 07:00 CET – Pixium Vision SA (Euronext Growth Paris – FR0011950641; Mnemonic: ALPIX), a bioelectronics company developing innovative bionic vision systems to help patients who have lost their sight to live more independently, today announced its financial statements by patient Enrolled in the pivotal PRIMAvera study in atrophic dry age-related macular degeneration (dry AMD), also known as geographic atrophy.

A total of 38 patients were enrolled in the PRIMAvera study (NCT04676854), an open-label, baseline-controlled, non-randomized, pivotal, multi-centre, prospective, single-arm study. A waiting list for additional patients has also been established to replace any of the current 38 patients who may prove unsuitable for implantation or who may drop out prior to implantation. The PRIMAvera study aims to confirm the safety and clinical utility of the Prima system and is the final clinical step prior to filing for marketing approval in Europe.

The study started in France in Q4 2020, where the first patient was enrolled in December 2020. Pixium Vision has since established additional clinical sites and implanted patients in France, Germany, the UK, the Netherlands and Italy. The implantations are expected to be completed by the end of 2022 and an evaluation of the primary endpoints of the PRIMAvera study is expected towards the end of 2023.

“We’re really glad Target number of patients reached in our registration-relevant PRIMAvera study, which has developed excellently…