Pixium Vision Announces Implantation of First Patient in Italy in Prima System European Pivotal Trial PRIMAvera
Pixium Vision announced the successful first implantation of a patient in Italy in the PRIMAvera pivotal trial in atrophic dry age-related macular degeneration (dry AMD). This follows the approval of the PRIMAvera study by the Italian Ministry of Health and the opening of the first clinical site in Italy at the Complesso Ospedaliero San Giovanni Addolorata.
Pixium Vision is the developer of the Prima System sub-retinal miniature photovoltaic wireless implant, which is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD).
The PRIMAvera study aims to confirm the safety and the 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. Pixium Vision has since established additional clinical sites and implanted patients in Germany, the UK, and the Netherlands.
"We are very pleased to have successfully implanted the first patient in Italy with the Prima System as part of the expanding PRIMAvera pivotal study," Prof. Andrea Cusumano, co-investigator of the PRIMAvera study for Italy, said in a company news release. "We have been following the development of the Prima System since its inception and we have seen the significant promise it shows for those suffering from dry AMD, a disease for which we struggle to provide acceptable solution and hope to patients and their families. PRIMA's small size and wireless design means the implantation is a straightforward procedure which can be completed with minimal surgery. We will move ahead now with further implantations and we look forward to adding our efforts to the clinical assessment of this innovative technology."
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.
A total of 38 patients will be implanted in the PRIMAvera study, an open-label, baseline-controlled, non-randomized, multicenter, prospective, single-arm pivotal trial. The primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 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 3 years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.
The implantation of patients has been performed at five sites in France, four in Germany, as well as the Moorfields Eye Hospital in the UK, the Rotterdam Eye Hospital in the Netherlands and Complesso Ospedaliero San Giovanni Addolorata in Italy. Pixium Vision anticipates recruitment will be completed by the end of 2022 leading to a read-out of the PRIMAvera study around the end of 2023.