Prima System French feasibility study
- PRIMA implant is well tolerated and safe in patients 36 months after implantation
- Implant is highly stable with no lifetime deteriorations observed
- PRIMA can potentially provide meaningful visual acuity improvement
Dr.
PRIMA, Pixium’s proprietary subretinal implant for Atrophic Dry AMD, was 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 for up to 36 months post implantation, demonstrating no implant lifetime failure. These observations are in line with in vitro reliability studies that showed the implants to be 100% reliable with pixels reliability of over 90%, for over 20 years.
Results from the feasibility study of compensation for blindness with the Prima System in patients with Dry AMD have shown:
- A significant improvement of to up logMAR 0.9 in visual acuity
- PRIMA implants are well tolerated and safe in the implanted subjects
- Integration of natural and artificial vision
- No decrease of residual natural visual acuity in any of the patients
- Unprecedented improvement in daily reading tasks demonstrating the feasibility of living with PRIMA
Following the successful results of the French feasibility study, the PRIMA implants and Prima System entered PRIMAvera, a European pivotal study design. A total of 38 patients will be enrolled in PRIMAvera, an open label, baseline-controlled, nonrandomized, multi-center, prospective, single-arm confirmatory trial. The primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 month and the primary safety endpoint is the number and severity of device and procedure related serious adverse events at 12 months follow-up. The study will include three years of follow-up, with assessment of the primary endpoints at 12 months after implantation.
The French feasibility study (NCT03333954) enrolled 5 patients who were implanted with the PRIMA sub-retinal implant in one eye. Following a successful rehabilitation process, implanted patients have shown significant improvement in visual acuity.
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