Pixium Vision continues favorably in discussions with the FDA for the development of PRIMA…

The assessment of PRIMA in the United States continues in the framework of the program of feasibility study early

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The development of PRIMA accepted in the dry form of Macular Degeneration Related to Age (dry AMD), a major medical need not covered

Paris, June 13, 2017 – 7:00 CET – Pixium Vision (FR0011950641 – PIX), a company that develops vision systems bionics innovative to enable patients with vision loss to live more independently, continuing its discussions with the u.s. Food and Drug Administration (FDA) in a favourable context, in order to prepare the first settlements clinical human of PRIMA, her second system incorporating an implant photovoltaic subretinal miniaturized.

All of the clinical data, reinforced by the evidence presented during the world congress of the Association for Research in Vision and Ophthalmology (ARVO) in may 2017, in particular the data of behavioral analysis in the non-human primate, has been discussed with the FDA in the context of the review of the regulatory process in the United States. Pixium Vision is working to complete a record of assessment for a clinical study of feasibility early (Early Feasibility Study) in the dry AMD. The feasibility program of early assessment, in a limited number of patients, medical devices, and in order to validate the concept of therapy and safety.

Khalid Ishaque, ceo of Pixium Vision, said : “Our constructive political dialogue and regular with the FDA continues in order to obtain authorization to conduct a first clinical trial in Humans. The registration authorities, in their strict process of evaluation, often require additional data, in particular for a first evaluation of the human clinical. Given the innovative and advanced therapeutic expected with PRIMA, the program for Early Feasibility Study is appropriate for a first study in Humans that the program Expedite Access Pathway (EAP). Our most recent data, including those presented recently at the conference of the ARVO 2017, allow the FDA to continue with the evaluation of the safety and potential therapeutic relevance of PRIMA in the dry form of AMD. “.

Pixium Vision is actively pursuing the development of PRIMA, and continues to enrich the discussions regular and constructive engagement with the regulatory authorities in europe and the united states in charge of assessing a feasibility study in Human clinical, is expected in 2017.


The mission of Pixium Vision is to create a world of vision bionics to allow those who have lost the order to recover some of their visual perception and to gain autonomy. Vision systems, bionic Pixium Vision are associated with a surgery and a rehabilitation period.
The company develops two vision systems, and bionics. IRIS®II, the first system has obtained the CE mark in July 2016. In parallel, Pixium Vision has recently finalized phases of preclinical studies of PRIMA, an implant photovoltaic subretinal miniaturized and wireless, and plans to start the first clinical trials in Humans.
Pixium Vision is working in close collaboration with academic partners of world renown such as the Vision Institute in Paris and the Laboratory of experimental physics Hansen at Stanford University and Moorfields Eye Hospital in London. The company is certified IN ISO 13485.

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