Pixium Vision SA announced 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 Fourth Quarter 2020 in France. Pixium Vision has since established additional clinical sites and implanted patients in Germany, the UK and the Netherlands. 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.

The implantation of patients has been performed at five sites in France, four in Germany as well as the Moorfields Eye Hospital in the UK, the Rotterdam Eye Hospital in the Netherlands and Complesso Ospedaliero San Giovanni Addolorata in Italy. Pixium Vision anticipates recruitment will be completed by the end of 2022 leading to a read-out of the PRIMAvera study around the end of 2023.