First Patient in Italy Implanted With Pixium’s Bionic Vision System

Italy has now joined the consortium of patients implanted with a bionic eye system undergoing a clinical trial evaluation for atrophic dry age-related macular degeneration (dry AMD) treatment. 

The system’s first successful implant in an Italian patient follows the approval of Pixium Vision SA’s PRIMAvera study by the Italian Ministry of Health and the opening of the first clinical site in Italy at the Complesso Ospedaliero San Giovanni Addolorata. The PRIMAvera study aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking European market approval. The study was initiated in Q4 2020 in France. Pixium Vision has since established additional clinical sites and implanted patients in Germany, the U.K. and the Netherlands.
 
“We are very pleased to have successfully implanted the first patient in Italy with the Prima System as part of the expanding PRIMAvera pivotal study,” said Prof. Andrea Cusumano, co-investigator of the PRIMAvera study for Italy. “We have been following the development of the Prima System since its inception and we have seen the significant promise it shows for those suffering from dry AMD, a disease for which we struggle to provide acceptable solution and hope to patients and their families. PRIMA’ssmall size and wireless design means the implantation is a straightforward procedure which can be completed with minimal surgery. We will move ahead now with further implantations and we look forward to adding our efforts to the clinical assessment of this innovative technology.”
 
The PRIMAvera study design is based on the positive data generated in a French feasibility study, showing the ability of patients with dry AMD to improve visual acuity with the Prima System. A total of 38 patients will be implanted in the PRIMAvera study, 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 include three years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.
 
The implantation of patients has been performed at five sites in France, four in Germany as well as the Moorfields Eye Hospital in the U.K., the Rotterdam Eye Hospital in the Netherlands, and Complesso Ospedaliero San Giovanni Addolorata in Italy. Pixium Vision expects to complete trial recruitment by the end of this year, leading to a read-out of the PRIMAvera study near late 2023.
 
The Prima System is intended to partially replace the normal physiological function of the eye’s photoreceptor cells by electrically stimulating the nerve cells of the inner retina, which then transmit the visual information to the brain via the optic nerve. It is designed to elicit functional artificial, or bionic, vision in the form of light perception replacing partially the natural central vision loss. The Prima System is composed of three main elements: a wireless retinal implant, a pair of glasses with a camera and digital projector, and a pocket processor.
 
Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. The company collaborates closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, Pa. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.