The Prima System, a photovoltaic substitute of photoreceptors, provides simultaneous use of the central prosthetic and peripheral natural vision. The company designed the implant for patients with atrophic dry age-related macular degeneration (AMD).
It aims to partially restore vision for these patients, according to a news release.
Under the breakthrough program, Pixium Vision said it can interact with the FDA’s experts during the premarket review phase. It expects to use this to identify areas of agreement in a timely way, potentially leading to prioritized review.
“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 conditions1,” said Lloyd Diamond, CEO of Pixium Vision. “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.”
Pixium Vision announced that it completed implants in a European pivotal trial in December 2022. It confirmed a read-out of primary endpoints at the end of 2023. The company then plans to submit for European approval in the first half of 2024.
A French feasibility study demonstrated the ability of dry AMD patients to improve visual acuity with Prima. Pixium said it based the European study design on the positive data generated in that feasibility study. That included an improvement in visual acuity of logMAR 0.2 or more from baseline after one year.
