The FDA has granted Breakthrough Device Designation to Pixium Vision SA’s novel Prima Bionic Vision System, designed for partially restoring vision in patients with atrophic dry age-related macular degeneration (AMD).
Refresh me on what a breakthrough therapy designation is.
A breakthrough therapy designation is intended to expedite the development and review process for new medical devices or drugs designed to treat or diagnose a serious or life-threatening disease.
In order to qualify, a medical device needs to have either breakthrough technology, no approved/cleared alternatives, significant advantages compared to any existing approved/cleared alternative devices, or have its availability be in the best interest for its target patients.
How about this company?
Established in 2011, Pixium Vision is a bioelectronics and brain machine interface technology company based in Paris, France, that develops bionic vision systems to enable partial visual perception for patients with vision loss.
Now talk about this Prima System.
The Prima Bionic Vision System is designed to partially replace the normal biological function of the eye’s photoreceptor cells through electrical stimulation of the nerve cells within the inner retina, which in turn transmits visual information to the brain via the optic nerve.
The minimally invasive, subretinal implant includes three main components: a wireless retinal implant, pair of glasses with a camera and digital projector, and a pocket processor.
What has clinical data shown so far?
A French feasibility study (NCT03333954) on the Prima System reported positive long-term results, demonstrating that the implant was well-tolerated, highly stable, and favorable safety profile in 5 dry AMD patients 36 months post-implantation; and a meaningful visual acuity (VA) improvement was observed.
A read-out of the study’s primary endpoints is expected toward the end of 2023, with a potential European regulatory submission in early 2024.
Anything else?
An open-label, baseline-controlled, non-randomized, multi-center, prospective, single-arm European pivotal trial (NCT04676854) referred to as PRIMAvera which has implanted 38 patients (diagnosed with dry AMD) with the Prima System.
According to Clinical Trials, the PRIMAvera study completion is expected in February 2026.
How about in the US?
An early, open-label feasibility trial (NCT03392324) has enrolled and implanted five dry AMD patients (age 60+) with the Prima System.
Near VA is being assessed in patients 12 months after implantation (primary outcome measure) as well as 3, 6, 9 18, 24, and 36 months after. VA, reading acuity tests, and quality of life will also be measured at incremental months.
When can we expect results?
According to Clinical Trials, the study is expected to be completed in December 2025.
What’s next?
The premarket review phase begins, where Pixium Vision will work with the FDA to identify areas of agreement. The company could also potentially receive prioritized review of the system’s U.S. regulatory submission. Stay tuned!