- The target number of 38 patients have been enrolled at clinical sites in
France ,Germany , theUK ,the Netherlands , andItaly - 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
The study was initiated in Q4 2020 in
"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
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.
About
Forward-Looking Statements. This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors (“Facteurs de Risques”) section of the Company’s 2021 Half-Year Financial Report and other documents the Company files with the AMF, which is available on the AMF website (www.amf- france.org) or on the Company’s website.
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