Prima System receives breakthrough device designation for dry AMD treatment
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Key takeaways:
- The Prima System received breakthrough device designation for use in patients with dry age-related macular degeneration.
- The PRIMAvera European trial is evaluating the efficacy and safety of the system.
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.
Image: Adobe Stock
Pixium completed implantations of the Prima System as part of the PRIMAvera European pivotal trial in 2022. A readout of the study’s endpoints is expected around the end of this year, with a regulatory submission possible in Europe in 2024. PRIMAvera is evaluating the efficacy of the system through improvement in logMAR visual acuity and safety through the number and severity of device- and procedure-related serious adverse events at 12 months.
“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 U.S. regulatory submission,” Lloyd Diamond, CEO of Pixium Vision, said in the release. “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.”
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