Pixium Vision (EPA:PIX) yesterday announced the first successful trial implantation and activation of its Prima next-generation miniaturized wireless photovoltaic sub-retinal implant, and that the system successfully produced visual perception.
With the implantation complete, the patient will begin the re-education phase of the study which includes a six-month and 36-month follow-up, the Paris-based company said.
“This first successful activation is a major milestone, validating Prima’s concept in patients with advanced dry AMD. 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,” Prima system inventor Dr. Daniel Palanker of Stanford University said in a press release.
Pixium Vision said its study of the device aims to explore the use of the Prima system in eliciting central visual perception in patients with lost sight due to atrophic advanced dry age-related macular degeneration, and looks to recruit up to five patients. Evaluations in the trial are slated for six months and 36 months.
The first implantation of the system was performed by principal investigator Dr. Yannick Le Mer at Paris’ Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt, the company said.
“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 one-month post implantation as per the protocol. 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,” Dr. Le Mer said in a prepared statement.
“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,” CEO Khalid Ishaque said in a prepared release.
Earlier this month, Pixium Vision said it won FDA approval to launch a clinical feasibility trial of its Prima implant designed to treat patients with atrophic dry age-related macular degeneration.