The FDA granted breakthrough device designation to the Prima System, an implant designed to partially restore vision in patients with atrophic dry age-related macular degeneration, Pixium Vision announced.
The designation will allow Pixium to interactively communicate with the FDA during the premarket review phase of the Prima System, a subretinal miniature photovoltaic wireless implant, and could allow prioritized review of the regulatory submission, according to a company press release.
Pixium completed implantations of the Prima System as part of the PRIMAvera European pivotal trial in 2022.