(News Bulletin 247) – Pixium Vision announced on Monday that it had reached the recruitment objectives of its European pivotal study, the implementation of which should be completed by the end of the year.
The specialist in bionic vision systems indicates that it has recruited, in accordance with its objectives, 38 patients have been recruited from clinical sites in France, Germany, the United Kingdom, the Netherlands and Italy.
The study, dubbed ‘PRIMAvera’, aims to confirm the safety and clinical benefits of its Prima system for patients who initially lost sight due to retinal degeneration due to the dry form of age-related macular degeneration (dry AMD).
The results of the study, which is the last clinical step before the European marketing authorization application, are expected to be presented by the end of 2023.
According to analysts at London-based research firm Edison, Pixium could obtain marketing authorization and begin marketing the product in the first half of 2025.
On the Paris Stock Exchange, Pixium Vision shares were up almost 6% on this information.
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