Pixium Vision Completes Implantations in the European Pivotal Trial PRIMAvera

Pixium Vision SA announced the completion of implantations in all the patients enrolled in the PRIMAvera European pivotal trial in geographic atrophy.

A total of 38 patients have been implanted with the Prima System in the PRIMAvera study (NCT04676854), an open-label, baseline-controlled, non-randomized, multicenter, prospective, single-arm pivotal trial. The 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 is being conducted in clinical centers in France, Germany, the UK, the Netherlands, and Italy. A read-out of the PRIMAvera study's primary endpoints is expected around the end of 2023.

"This is an important milestone in the clinical development of our innovative Prima System, and we are very pleased to have reached it successfully," Lloyd Diamond, Chief Executive Officer of Pixium Vision, said in a company news release. "I'd like to thank all the physicians and patients involved in the PRIMAvera study as well as the whole Pixium team for their hard work in contributing to this significant achievement. We are now looking ahead to next year's read-out on the primary endpoints. From there we expect to be able to start discussions with the European regulator in preparation for bringing this cutting-edge technology to market for the benefit of those suffering from the loss of their sight due to dry AMD. Along with the US and French feasibility studies, we expect that the data from the PRIMAvera pivotal study will also play an important supporting role in the US regulatory submission.”

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 3 years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.