Pixium Vision, a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announces the first successful Prima System implantation of a patient in the US suffering from dry-AMD. The patient, recruited in the course of the US feasibility study, underwent the procedure at the Department of Ophthalmology of the University of Pittsburgh Medical Center (UPMC), led by Professor José A. Sahel*, co-founder of Pixium Vision and director of the UPMC Eye Center.
“The implantation of the first patient in the US is an important milestone for Pixium Vision and a key step towards developing a treatment for a significant unmet medical need. We thank the patient, family and the medical team at UPMC in opening a new chapter for Pixium Vision in the US, which we have worked towards in close cooperation with the FDA and the hospital,” says Lloyd Diamond, Chief Executive Officer of Pixium Vision. “This first patient is one of the five planned in the US feasibility study who will add to Prima’s clinical dataset in view of the upcoming pivotal trial of the Prima System in dry-AMD, which we plan to file in H1 2020. This trial will pave the way for regulatory approval.”
The procedure was the first to use Pixium Vision’s newly developed and proprietary implantation device, which is designed to ease the surgical procedure and lower any potential side effects. After a healing period lasting around one month, the patient will start the rehabilitation process, using the newest generation Prima System allowing for the combination of both natural residual vision and prosthetic vision. The new Prima System includes proprietary transparent glasses which have recently been introduced among patients treated in France. The preliminary results are encouraging and should be made available in Q1 2020.
“We are proud to be the first US center to participate in the clinical assessment of this promising technology,” says Joseph N Martel, MD, the implanting retinal surgeon. “We look forward to accompanying the patient in their rehabilitation process to better understand the full potential of the Prima System in helping to improve the quality of life in patients with dry-AMD, a disease for which currently there is no treatment.”
The US feasibility trial, conducted both at UPMC and Bascom Palmer Eye Institute in Miami, is running in parallel with the French first-in-human trial. Both trials are evaluating the Prima System in patients afflicted with an advance form of dry-AMD. The 12-month results from the French trial already demonstrated the ability of most of patients to identify sequences of letters, and there were no device-related serious adverse events.
PRIMA is a new generation miniaturized and totally wireless sub-retinal implant. The 2×2 millimeters wide and 30 microns thick photovoltaic chip contains 378 electrodes. Implanted under the retina via a minimally invasive surgical procedure, it acts like an array of tiny solar panels powered by pulsed near infrared light projected from a miniature projector integrated into augmented reality glasses, along with a mini camera. PRIMA is designed to restore sight in patients blinded by retinal dystrophies – a very significant unmet medical need. The target population includes patients with atrophic dry Age-related Macular Degeneration (dry AMD), and Retinitis Pigmentosa (RP). In addition to a clinical trial with five atrophic dry-AMD patients in France, PRIMA is approved for a similar five-patients study in USA.