Pixium Vision announces positive long-term follow-up
Pixium Vision positive announcement long term to follow-scientific data on the PRIMA implant of
French feasibility study Prima System
- PRIMA implant is well tolerated and safe in patients 36 months after implantation
- The implant is very stable and no deterioration in service life is observed
- PRIMA has the potential to provide significant improvement in visual acuity
Paris, France, 13.10.2021 – 07:00 CET – Pixium Vision SA (Euronext Growth Paris – FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable blind patients to live more independent lives, announces positive long-term patient data implanted with PRIMA, a state-of-the-art implantable chip. The data was presented during The Eye and The Chip – Virtual Event, which was held October 3-5, 2021.
Dr Yannick Le Mer, head of the vitreoretinal unit at the Adolphe de Rothschild Foundation hospital in Paris and principal investigator of the pivotal PRIMAvera study, commented: “I was delighted to present such positive scientific data on PRIMA, our owner revolutionary wireless subretinal implant. PRIMA can be implanted easily without causing serious or incurable complications. In addition, the implant is spectaclem be reliable among the sick for more 36 monthss post-implantation. These encouraging results position by Pixium PRIMA implant, and all the Prima System, like a realistic potential solution for people who suffer from loss of central vision due to to dry Macular degeneration (To dry AMD), a large population of patients without solutions to improve their poor quality of life currently on the market.“
PRIMA, Pixium’s proprietary subretinal implant for dry atrophic AMD, has been shown in clinical trials to be easily and safely implanted in patients, thanks to the unique design of the implant itself and Pixium’s proprietary delivery system used for implantations (Figure 1).
In the French feasibility study, five patients were observed and followed up to 36 months after implantation, demonstrating no lifelong implant failure. These observations are in line with in vitro reliability studies which have shown implants to be 100% reliable with pixel reliability of over 90%, for over 20 years.
The results of the feasibility study of compensating blindness with the Prima System in patients with dry AMD showed:
- Significant improvement in visual acuity up to logMAR 0.9
- PRIMA implants are well tolerated and safe in implanted subjects
- Integration of natural and artificial vision
- No decrease in residual natural visual acuity in any patient
- Unprecedented improvement in daily reading tasks demonstrating the feasibility of living with PRIMA
Following the positive results of the French feasibility study, the PRIMA and Prima System implants have entered PRIMAvera, a European pivotal study design. A total of 38 patients will be included in PRIMAvera, an open-label, benchmark-controlled, non-randomized, multicenter, prospective, single-arm confirmatory trial. The primary efficacy endpoint is the proportion of subjects with an improvement in visual acuity of 0.2 logMAR or more from baseline up to 12 months and the primary endpoint of l Safety is the number and severity of serious adverse events related to the device and procedure at 12 month follow-up. The study will include three years of follow-up, with an evaluation of the main endpoints at 12 months after implantation.
The French feasibility study (NCT03333954) included 5 patients who were implanted with the PRIMA subretinal implant in one eye. After a successful rehabilitation process, the implanted patients showed a significant improvement in visual acuity.
On Pixium Vision
Pixium Vision creates a world of bionic vision for those who have lost their sight, allowing them to regain visual awareness and greater autonomy. Pixium Vision’s bionic vision systems are associated with surgery and a period of rehabilitation. The Prima System miniature wireless subretinal photovoltaic implant is undergoing clinical testing for patients who have lost their sight due to external retinal degeneration, initially to age-related atrophic dry macular degeneration (dry AMD ). Pixium Vision works closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as: Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University Hospital Bonn and UPMC in Pittsburgh, Pennsylvania. The company is EN ISO 13485 certified and qualified as an “Innovative Company” by Bpifrance.
For more information: http://www.pixium-vision.com/fr
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