• The target number of 38 patients have been enrolled at clinical sites in France, Germany, the UK, the Netherlands, and Italy
• Waiting list for additional patients initiated to replace potential pre-implantation drop-outs and ineligibility
• Implantations due to be completed by the end of 2022; PRIMAvera read-out expected around the end of 2023

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 Q4 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.

“We are very pleased to have reached the target patient number in our pivotal PRIMAvera study, which has been making great progress since it was initiated in late 2020,” said Professor Frank Holz, the lead investigator for Germany and scientific coordinator of the PRIMAvera study. “We are excited to be advancing this innovative technology towards the market where patients suffering from dry AMD could benefit. We are looking forward to completing the implantations by the end of the year and announcing the study’s read-out 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.