Pixium Vision announces publication in Ophthalmology of promising Prima System data in dry AMD

• Prima System improves central visual acuity in geographic atrophy
• Surgical implantation has no impact on peripheral natural vision
• Electronic magnification may further improve visual acuity with the second generation of glasses

Paris, 2 March 2020 – 5.45 pm CET– Pixium Vision (FR0011950641 - ALPIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independently, today announces the publication of an article in Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology (AAO), on the potential of the Prima System to stimulate inner retinal neurons.

The article, entitled “”, covered the first-in-human clinical trial with the Prima System to test its safety and efficacy in patients suffering from geographic atrophy (GA), which is also known as dry age-related macular degeneration (AMD). This first-in-human trial in France is running in parallel with a US feasibility study and both are evaluating the Prima System in patients afflicted with dry AMD.

The study demonstrated that implantation of the Prima System is feasible, maintained the level of residual natural acuity and restored visual sensitivity in the former scotoma in each of the five patients. The article published in Ophthalmology concluded that the use of optical or electronic magnification in future glasses may improve visual acuity even further and reinforces the 12-month results from the French trial, which have demonstrated the ability of most of the patients to identify sequences of letters, with no device-related serious adverse events.

“We are very pleased to present exciting results of the first clinical trial with the Prima System, which demonstrated feasibility of restoration of central vision in patients blinded by dry age-related macular degeneration,” says Prof. Daniel Palanker, PhD, of Stanford University, the author of the article and a scientific advisor to Pixium Vision. “The fact that prosthetic acuity closely matches the pixel size of the implant indicates that the use of image magnification should improve visual acuity even further. The Prima System is now equipped with second generation glasses which combine natural residual vision with prosthetic vision, and we are looking forward to the first clinical data by the end of Q1 2020.”

The loss of photoreceptors in dry AMD affects over 5 million patients worldwide¹ and over 1 million² in the US, and results in severe central vision impairment.

“These data further confirm the ease of use of the Prima System and we are excited about its potential to improve the quality of life for patients with geographic atrophy who currently have no treatment options. The testing of the second generation glasses should further improve the benefit of the Prima System in daily life,” says Dr Yannick le Mer, Head of the Vitreo-retinal Unit at Fondation Adolphe de Rothschild Hospital in Paris, a co-author of the paper, scientific advisor to Pixium Vision and the surgeon who implanted the Prima System patients in the French trial.

Contacts

Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision 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.

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¹ Tufail A, et al. Objective Measurement of Reading Speed and Correlation With Patient-Reported Functional Reading Independence. Presented at the 15th EURETINA Congress, Nice, France, September 17-20, 2015

² The Eye Diseases Prevalence Research Group. Prevalence of Age-Related Macular Degeneration in the United States. Arch Ophthalmol. 2004;122:564-572

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