Pixium Vision SA announces the completion of patient enrollment in the PRIMAvera pivotal trial in atrophic dry age-related macular degeneration (dry AMD), also known as Geographic Atrophy. A total of 38 patients have been enrolled in the PRIMAvera study (NCT04676854), an open-label, baseline-controlled, non-randomized, multi-center, prospective single-arm pivotal trial. A waiting list for additional patients has also been established to replace any of the current 38 patients who could prove ineligible for implantation or drop out before implantation takes place.

The PRIMAvera study aims to confirm the safety and clinical 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, 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.

Implantations are due to be completed by the end of 2022, and a read-out of the PRIMAvera study's primary endpoints is expected around the end of 2023.