Pixium Vision SA announced the approval of the remote rehabilitation system for patients enrolled in the PRIMAvera pivotal trial and the French Feasibility Study in atrophic dry age-related macular degeneration (AMD). The approval was granted by the Ethics Commitee and the Regulatory Authorities. This first feature of Pixium Vision's new remote patient engagement platform will allow patients to conduct rehabilitation sessions from home, with or without the help of a family member or a caregiver.

The platform requires only a tablet, provided by Pixium, and an internet connection to be fully functional. Over the coming months, more innovative features are expected to be added to the platform to help dry AMD patients live a more independent life. The PRIMAvera study aims to confirm the safety as well as the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe.

The study was initiated in Fourth Quarter 2020 in France, and the first patient was implanted in March 2021. Pixium Vision has since established clinical sites and implanted its first patients in Germany, the UK and the Netherlands. The opening of additional clinical sites is planned in Spain, and Italy during 2022.

Pixium Vision expects to complete recruitment by the end of 2022, leading to a read-out of the PRIMAvera study around the end of 2023 and a regulatory submission in Europe in H1 2024. Remote rehabilitation has been approved in France, Germany, Italy, Spain and the Netherlands for patients who have succesfuly completed their initial in-clinic rehabilitation sessions. The remote rehabilitation sessions will take place between the patient and the rehabilitation specialists and will be of the same nature as the in-clinic rehabilitation sessions.

The platform will also allow clinicians to track the progress of patients at any time and to adjust the frequency of the remote rehabilitation sessions based on the progress of each patient. Given the age and lack of vision of the patients enrolled in the clinical studies, remote rehabilitation will make it simpler for patients to comply. Pixium Vision's unique remote patient engagement platform is a tailor-made solution to ensure appropriate rehabilitation.