Pixium Vision SA announced the completion of implantations in all the patients enrolled in the PRIMAvera European pivotal trial in atrophic dry age-related macular degeneration (dry AMD), also known as Geographic Atrophy. A total of 38 patients have been implanted with the Prima System in the PRIMAvera study (NCT04676854), an open-label, baseline-controlled, non-randomized, multi-center, prospective, single-arm pivotal trial. The 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 is being conducted in leading clinical centers in France, Germany, the UK, the Netherlands, and Italy. A read-out of the PRIMAvera study's primary endpoints is expected around the end of 2023. 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.

The primary efficacy endpoint of the PRIMAvera study is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline after 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.