The Prima System is designed as a photovoltaic substitute for photoreceptors that offers simultaneous use of the central prosthetic and peripheral natural vision
The Prima System is intended to partially restore vision of patients with atrophic dry AMD. (Credit: Max Muselmann on Unsplash)
Pixium Vision has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Prima System for the treatment of patients with atrophic dry age-related macular degeneration (AMD).
The French bioelectronics company has designed the Prima System as a photovoltaic substitute of photoreceptors that offers simultaneous use of the central prosthetic and peripheral natural vision.
According to Pixium Vision, the sub-retinal miniature photovoltaic wireless implant intends to partly restore eyesight of patients with atrophic dry AMD.
The breakthrough device status will enable the bioelectronics company to interact with the FDA’s experts during the premarket review stage of the Prima System.
Pixium Vision said that it will aim to find areas of agreement in a timely manner to get a prioritised review of the regulatory submission.
Pixium Vision CEO Lloyd Diamond said: “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.”
In December last year, Pixium Vision completed implantations of the Prima System in a European trial called PRIMAvera in dry AMD patients.
The design of the PRIMAvera study is based on the positive data produced in a feasibility study held in France, which demonstrated the ability of patients with dry AMD to improve their visual acuity with the investigational implant.
The read-out of primary endpoints of PRIMAvera is anticipated at the end of this year.
Pixium Vision aims to make a regulatory submission in the first half of 2024 in Europe.
Last year, the bioelectronics firm announced the FDA’s approval of the expansion of its feasibility study of the photovoltaic wireless implant in the US to include Stanford Medicine as a clinical site.