Pixium Vision announces geographical expansion of PRIMAvera European pivotal study with opening of first UK clinical site at Moorfields Eye Hospital
Pixium Vision announces geographical expansion of PRIMAvera European pivotal study with opening of first UK clinical site at Moorfields Eye Hospital
- London’s Moorfields Eye Hospital is the premiere ophthalmology center in the UK
- PRIMAvera study is the last clinical step before seeking European approval
Paris, France, August 132021 – 07.30 CET– Pixium Vision SA (Euronext Growth Paris - FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the geographical expansion of the PRIMAvera European pivotal trial in atrophic dry age-related macular degeneration (AMD) with the opening of the first clinical site in the UK at the Moorfields Eye Hospital in London.
The Moorfields Eye Hospital in London, the premiere ophthalmology center in the UK, can now recruit patients into the PRIMAvera study, which aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe. The study was initiated in Q4 2020 in France and the first patient was implanted in March 2021. The PRIMAvera study is planned to expand to additional clinical sites in Germany, Spain, the Netherlands and Italy over the course of H2 2021.
Lloyd Diamond, CEO of Pixium Vision, commented: “The opening of our first PRIMAvera clinical center in the UK is another important landmark as our pivotal trial continues to make good progress. We are particularly proud that such a prestigious clinical center as the Moorfield Eye Hospital joins our efforts to confirm the safety and efficacy of the Prima System. This study builds on the excellent results shown by the Prima System in clinical trials so far and we are excited to bring this bionic vision system to more patients and make further progress towards generating more data and filing for approval.”
Mahi Muqit, Consultant Ophthalmologist and Cataract and Vitreoretinal Surgeonat Moorfields Eye Hospital, commented:“We are pleased to now be open for recruitment in the PRIMAvera pivotal trial at Moorfields Eye Hospital and invite potential patients affected with dry-AMD to reach-out to us. The Prima System has the potential to significantly improve vision and quality of life for patients with dry AMD and I am looking forward to bringing it to more patients in need.”
The PRIMAvera study design is based on the positive data generated in a French feasibility study, showing the ability of patients with dry AMD to potentially improve in visual acuity with the Prima System. Patients had a meaningful improvement in vision, gaining on average a logMAR of 0.5 (corresponding to 5 lines of improvement).
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.
About Pixium Vision
Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates 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 in Bonn, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
For more information: http://www.pixium-vision.com/fr
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Contacts
| Pixium Vision Offer Nonhoff Chief Financial Officer investors@pixium-vision.com +33 1 76 21 47 68 |
Media Relations LifeSci Advisors Sophie Baumont sophie@lifesciadvisors.com +33 6 27 74 74 49 |
Investor Relations LifeSci Advisors Guillaume van Renterghem gvanrenterghem@lifesciadvisors.com +41 76 735 01 31 |
