Pixium Vision announces its PRIMA chip successfully met interim study endpoints for dry AMD
Pixium Vision announces its wireless PRIMA chip successfully met the interim study endpoints for dry Age-related Macular Degeneration
- Implant is well tolerated while preserving residual peripheral visual acuity
- All subjects report light perception in their central visual field
- Majority of patients identifying complex patterns, letters or letter sequences
- Interim positive data enables to prepare the European multi Centre pivotal study
Paris, France. January 8, 2019 – 7.00 AM CET – Pixium Vision (FR0011950641 – PIX), a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announces its subretinal PRIMA system met the endpoints of the feasibility study,at interim 6 months follow-up after implantation and rehabilitation for patients with advanced dry Age-related Macular Degeneration (AMD).
Khalid Ishaque, Chief Executive Officer Pixium Vision, stated: “We are very pleased with the remarkable results being achieved with PRIMA system with dry AMD patients. These results exceeded our initial expectations. For patients who had completely lost their central vision, PRIMA enabled majority of them to begin to correctly identify patterns and letters. We expect these remarkable first results to attract also eligible candidates for the PRIMA feasibility study recruiting in the USA. Following this successfully significant milestone, we look forward to the pivotal clinical phase in Europe and subsequent CE Mark for PRIMA.”
The interim clinical results at 6 months with PRIMA, a wireless sub-retinal photovoltaic microchip, in patients with advanced dry-AMD, show:
- PRIMA can be safely implanted under the atrophic macula while preserving the residual natural peripheral visual acuity, measured under standardized conditions.
- Successful elicitation of light perception in the central retinal area in all subjects who had no remaining central visual activity, validated by standardized clinical vision measures and tests.
- The implant is well tolerated, with no device-related serious adverse events. Implant does not move after natural retina healing and remains stable in all patients.
- Identification of patterns, numbers, or letters, in a majority of the patients. The speed and accuracy of identifications improved continuously during the rehabilitation phase.
- Central prosthetic visual acuity,measured up to 20/460 (LogMAR 1.37) within the former scotoma with no remaining natural central vision. The achieved prosthetic visual acuity to date is the best among those published from current visual prosthetic technologies….
- Read more: https://www.nasdaq.com/press-release/pixium-vision–announces-its-prima-chip-successfully-met-interim-study-endpoints-for-dry-amd-20190108-00020
- Source: Nasdaq