Pixium Vision’s Prima System granted FDA Breakthrough Device Designation

pharmafile | April 3, 2023 | News story | Medical Communications  

French bioelectronics company Pixium Vision has been granted Breakthrough Device Designation by the FDA for its Prima System.


Prima System is a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision implanted in patients with atrophic dry age-related macular degeneration (AMD) to partially restore their vision.


The Prima System is currently being studied in the PRIMAvera clinical trial. In December 2022, it was announced that implantations of the Prima System were completed in trial participants. The primary endpoint of the study is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline after 12 months. There is also a primary safety endpoint which is the number and severity of device and procedure-related serious adverse events at 12 months follow-up. Primary endpoint data will be available at the end of 2023.


Lloyd Diamond, CEO of Pixium Vision, stated: “To receive this Breakthrough Device Designation and have the FDA recognise the therapeutic potential of our Prima System is a significant achievement for Pixium Vision, especially as only a small proportion of devices awarded the designation are intended to treat ophthalmologic conditions. Our Prima System is making great progress in the clinic with a read-out on the primary endpoints due toward the end of this year. This designation not only helps us to expedite the development of the Prima System but also affords us the opportunity of working closely with the FDA in refining the Prima System for its US regulatory submission. In addition, after receiving market authorisation, there are outpatient and inpatient reimbursement pathways that are more readily accessible as a result of receiving Breakthrough Device Designation.”


James Spargo

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