Pixium Vision announced on 20 November that it has received approval from the French regulatory health authority, ANSM, to start its PRIMAvera European pivotal study of its Prima Bionic Vision System (BVS) in patients with dry age-related macular degeneration with geographic atrophy (GA-AMD), a largely unmet market indication. This is an important milestone for Pixium as we believe the PRIMAvera European registration study may provide top-line 12-month data in H222, supporting our estimate of potential CE mark and European launch in H223.
