Pixium Vision SA, a bioelectronics company developing innovative bionic vision systems to enable patients with vision loss to live more independently, today announces the successful completion of the UK’s first patient implant as part of the pivotal PRIMAvera dry form study of age-related macular degeneration (AMD).
This implementation follows the approval of the PRIMAvera trial by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the opening of the first clinical site for the PRIMAvera trial at Moorfields Eye Hospital, London. The PRIMAvera study aims to confirm the safety and benefits of the Prima system and represents the final clinical step before applying for European Marketing Authorization. The study began in France in the fourth quarter of 2020 and the first implant was placed in March 2021. Since then, Pixium Vision has opened other clinical sites, implanted a first patient in Germany and plans to expand the number of clinical sites, particularly in Spain, the Netherlands and Italy in the first half of 2022.
“We are very proud to be part of the expansion of the pivotal PRIMAvera trial and look forward to helping bring this innovative bionic vision system to patients who need it,” said Dr. Mahi Muqit, ophthalmologist and specialist surgeon in cataract and vitreoretinal surgery at Moorfields. Eye hospital. “We have completed the first implantation of the Prima system in the UK and at Moorfields Eye Hospital. I am delighted because the simplicity of the procedure and short learning curve will enable retinal surgeons to perform this surgery with confidence; Prima- system could be life-changing for patients. Now that the first implant has been placed, we look forward to seeing the patient’s progress in the coming months.”
The PRIMAvera study design is based on the positive data generated by a French feasibility study showing that the Prima system can improve visual acuity in patients with dry AMD.
A total of 38 patients will be enrolled in the PRIMAvera trial, an open-label, prospective, multicenter, non-randomized, pivotal controlled trial. The primary efficacy endpoint is the proportion of subjects experiencing an improvement in visual acuity of at least 0.2 logMAR from baseline to the end of Month 12, and the primary endpoint of the safety assessment is the number and severity of device and procedure-related adverse events at 12 months of follow-up. The study includes three years of follow-up, with assessment of key endpoints 12 months after implant.
The results of the PRIMAvera study were initially expected to be available by the end of 2022, but obtaining official authorizations was delayed due to delays related to Covid-19, delaying the opening of clinical centers.
To date, implants have been performed at seven sites in France, six in Germany and now one in the UK, so Pixium expects the recruitment to be complete by the end of 2022, allowing the results of the PRIMAvera trial to be announced towards the end. from 2023.