Pixium Vision’s Prima System Earns Breakthrough Status

Pixium Vision has gained U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Prima System, a photovoltaic substitute of photoreceptors offering simultaneous use of the central prosthetic and peripheral natural vision implanted in human patients with atrophic dry age-related macular degeneration (AMD) to partially restore vision.
 
Pixium will have the opportunity to interact with FDA experts during Prima’s premarket review to identify areas of agreement in a timely way, and may also earn prioritized review of the regulatory submission.
 
“To receive this Breakthrough Device Designation and have the FDA recognize 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,” Lloyd Diamond, CEO of Pixium Vision told the press. “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 authorization, there are outpatient and inpatient reimbursement pathways that are more readily accessible as a result of receiving Breakthrough Device Designation.”
 
Pixium announced completion of implantations in its PRIMAvera European clinical trial in December 2022 and confirmed a read-out of the trial’s primary endpoints around the end of 2023. The company aims to seek European regulatory submission in the first half of 2024.
 
The PRIMAvera study design is based on 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 three years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.