A French bioelectronics company “Pixium Vision SA”, based in Paris, has announced the implantation of an artificial retina in a first patient in the UK. The pivotal trial (“PRIMAvera”) in atrophic dry age-related macular degeneration (dry-AMD) was performed in Moorfields Eye Hospital London. The company had since established additional clinical sites in Germany, and now plans to expand additional clinical sites in Spain, the Netherlands, and Italy throughout the first half of the year for 2022. According to the company, the PRIMAvera study will enrol 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”.
In follow up to the recent announcement on the first UK patient enrollment, Dr. Mahi Muqit, Consultant Ophthalmologist and Cataract and Vitreoretinal Surgeon at Moorfields Eye Hospital stated that, “[w]e are very proud to be part of the expansion of the PRIMAvera pivotal trial, and we are keen to help bringing this innovative system giving bionic vision to patients in need. It was the first implantation of the Prima System in the UK and at Moorfields Eye Hospital, and I was pleased by the simplicity of the procedure, making me confident that after overcoming the small learning curve, retinal surgeons will feel comfortable conducting this procedure, which can be life-changing for patients. Now that the patient has been implanted, we look forward to observing the progress the patient will make over the coming months”.