Pixium Vision - First Prima implantation in Italy

Pixium Vision announced the successful first implantation of a patient in Italy as part of the PRIMAvera pivotal trial assessing the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The expansion of PRIMAvera to Italy follows implantations occurring at sites in France, Germany, the UK and the Netherlands. The company reiterated its guidance that it expects to complete PRIMAvera study patient enrolment by year-end FY22, and to report primary endpoint data at around year-end 2023. The PRIMAvera study is the final clinical trial needed before European market authorisation can be sought, and we continue to estimate that Pixium could receive potential European market approval and launch the product in H125.