Although Pixium Vision is a Paris-based company, the initial conception of  PRIMA (Photovoltaic Retinal Implant) was developed at Stanford University.  The company began in 2011 with a team of specialists ranging from retinal surgery, to neurophysics, to electrophysiology.   This team of multidisciplinary specialists developed the Bionic Vision Restoration System (VRS) which consists of 4 components:

1. A miniature wireless sub-retinal implant or chip containing 378 electrodes
2. A headworn device consisting of a pair of glasses, a miniature camera, and a data transmitter
3. A pocket size high speed digital signal processor which can transform light into electrical signals
4. Proprietary software that can be adjusted for each patient to aid in their rehabilitation

The VRS works by stimulating the photoreceptor cells of the retina which via the optic nerve transmits information to the brain.  The goal for each patient is to restore some of their lost central vision with the potential of once again being able to recognize faces. The first clinical trial will be in patients who have an advanced form of dry age-related macular degeneration (AMD), also known as geographic atrophy or atrophic dry macular degeneration.  Symptoms of this retinal condition include dark grey, black, or blank spots in the center of one’s vision, known as scotomas. A patient’s peripheral vision remains intact.  One of the possible risks of this surgery is that it may interfere with or cause a loss of peripheral or side vision.  At this time there is no treatment for advanced dry AMD.

In October of 2017, the company received approval from the French regulatory agency, Agence Nationale de Sécurité du Médicament et des Produits de santé, to begin their first human clinical trial using their next generation PRIMA implant in patients who have advanced dry macular degeneration.  The PRIMA chip is surgically implanted in the subretinal space in a comparably shorter surgery of about 3 hours. The implant  measures 2 X 2 millimeter square and is 30 µm thick.  The first phase clinical trial will recruit 5 patients at the two study sites,  Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris, with vitreoretinal surgeon and ophthalmologist Yannick Le Mer as principal investigator.   The name of the study is Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Dry-AMD and the first implant is expected to occur before the end of the year.

Pixium is pursuing discussions with the US Food and Drug Administration (FDA) about a similar feasibility study with PRIMA in the US.

Leslie Degner, RN, BSN

www.WebRN-MacularDegeneration.com