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Pixium SA has announced the completion of implantations of the “PRIMAvera” trial with the implantation of a bionic artificial retina.

A French bioelectronics company “Pixium Vision SA” (Euronext Growth Paris – FR0011950641; Mnemo: ALPIX), based in Paris, has announced the completion of implantations of an artificial retina across clinical centers in France, Germany, the UK, the Netherlands, and Italy. A read-out of the PRIMAvera study’s primary endpoints is expected around the end of 2023.  According to the company, the PRIMAvera study enrolled a total of 38 patients with an open-label, baseline-controlled, non-randomized, multi-center, prospective, single-arm pivotal 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 months, 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 aim to include three years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.

Pixium-Vision S.A. was founded in Paris in December 2011 as a spin-out of the Vision Institute / Université Pierre et Marie Curie in Paris (with principals Professor Jose Sahel, Dr Bernard Gilly, Dr Serge Picaud, Dr Ryad Benosman and Dr Christoph Posch), to commercialise collaborative work involving a number of “top-tier academic groups”, including the French Atomic Energy Commission (Dr Philippe Bergonzo) and ESIEE (Dr Lionel Rousseau).  The initial financing of the opportunity (€9.5M in May, 2012) coincided with the purchase of certain assets, including a retinal implant technology, then controlled by Intelligent Medical Implant GmbH (“IMI”).  Pixium stated that the IRIS system consists of an intraocular implant (also known as “a retinal stimulator”) that is surgically placed into the eye of a patient epi-retinally or sub-retinally. A pair of spectacles containing an integrated mini-camera and wireless transmitter connect to a pocket computer worn at the patient’s waist, which processes the image captured by the camera into a signal that is transferred back through the spectacles onto the retinal implant to stimulate the ganglion cells and generate an image. According to the company earlier, “the brain learns to interpret the signals it receives from the implant during a structured rehabilitation program undertaken by patients after healing from the implant surgery”.

According to the announcement, Professor Frank Holz, Scientific Coordinator of the PRIMAvera study stated that, “I am proud to be leading the PRIMAvera pivotal study and of the progress we have made in opening multiple clinical sites across Europe and completing dozens of successful implantations.  It is a testament to the skill of the surgical teams involved in the study and to the technological integrity of the Prima System that the implantations have proceeded in such an efficient and expeditious manner. We also saw better-than-expected recruitment demonstrating a strong interest among patients suffering from late-stage atrophic age-related macular degeneration in the PRIMA implant and the study as a whole. We are looking forward to next year’s target read-out and to hopefully having the Prima System available to the many patients affected by dry AMD.”  In addition, Professor José-Alain Sahel, M.D., University of Pittsburgh School of Medicine and a co-founder of Pixium Vision commented that the “PRIMAvera pivotal study marks a major step forward in the treatment of atrophic dry AMD and it is very rewarding to see the Prima System progressing so well in a clinical setting. We have great confidence in the technology as Pixium has already demonstrated how the prosthetic central vision generated by the Prima System can be used simultaneously with patients’ remaining peripheral vision, indicating the technology’s potential to help improve the lives of those suffering from dry AMD, who currently have no other treatment options.”