Pixium Vision announced the first successful human implantation and activation of PRIMA, its new generation miniaturized wireless photovoltaic subretinal implant, in a patient with severe vision loss from atrophic dry age-related macular degeneration (AMD). The PRIMA Bionic Vision System successfully elicited visual perception. This enables the patient to start the re-education phase as per the trial protocol, which includes a 6-month follow-up and progress update.
This study is designed to evaluate the safety and performance of PRIMA in eliciting central visual perception among patients who have lost their central sight due to atrophic advanced dry-AMD. The study will recruit up to 5 patients with evaluation at 6-month follow-up, and longer-term follow-up to 36 months. Dr. Yannick Le Mer, pioneering ophthalmologist and retinal surgeon, performed the first PRIMA implantation as part of the feasibility clinical study of PRIMA in France being conducted at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris.
“This first successful PRIMA implantation results from its rigorous development and its testing phases. The smooth recovery of the patient was enabled also by the elegance of the surgical technique. Successful activation was achieved 1 month post-implantation as per the protocol,” Dr. Le Mer, principal investigator of the study, said in a company news release. “Following activation, the patient reported a first perception of light from the central zone where there was none previously. The patient now proceeds to the important re-education phase to learn to interpret the elicited light signals and evaluate the performance of the PRIMA system.”
“This first successful activation is a major milestone, validating PRIMA’s concept in patients with advanced dry AMD," Prof. Daniel Palanker, Stanford University, Dept. of Ophthalmology and inventor of PRIMA, said in the news release. "The close collaboration between our team at Stanford University and Pixium Vision has been critical for successful development and testing of PRIMA. We will continue to advance the photovoltaic implants in our lab, seeking further increases in resolution and in quality of the visual perception.”
Khalid Ishaque, Chief Executive Officer of Pixium Vision, said: “In Pixium’s mission to create a world of bionic vision for those with vision loss from retinal dystrophies, the team and partners have delivered a major milestone in the development of its new generation bionic vision system. PRIMA harnesses breakthrough innovations and new possibilities to address a significant unmet need, for which we are concentrating initially in atrophic dry-AMD. We look forward to completing the feasibility phase in France and starting the FDA approved US feasibility study.”
 Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Dry Age Related Macular Degeneration (PRIMA FS) https://www.clinicaltrials.gov/ct2/show/NCT03333954