Pixium Vision announces presentations of current clinical data with PRIMA implant during the American Academy of Ophthalmology annual congress

Chicago (USA) - October 26 - 30, 2018

Paris, France. October 23, 2018 - 6.00 PM CEST - Pixium Vision (FR0011950641 - PIX), a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced the presentation of preliminary clinical data from the French feasibility trial^[1] of PRIMA, its novel miniature wireless photovoltaic sub-retinal implant, during the annual congress of American Academy of Ophthalmology (AAO 2018), to be held in Chicago (USA) from October 26 to 30, 2018.

Two presentations will be given by Professor José A. Sahel, Chair of the Department of Ophthalmology at University of Pittsburgh School of Medicine, Head of the Department of Ophthalmology at Fondation ophtalmologique Rothschild (Paris) and Director of the Vision Institute (Paris):

• Retina Subspecialty Day on Friday, October 26^th, during Late Breaking Developments session from 4.20PM: "First Results of Photovoltaic Vision Restoration in Atrophic Dry Age-related Macular Degeneration."
   
• Paper Presentation on Monday, October 29^th , Room S405 from 4.00PM: "Photovoltaic Restoration of Central Vision in Atrophic Dry AMD."

The American Academy of Ophthalmology (AAO) selected the first clinical results of PRIMA to be presented during the late breaking developments session during the Retina sub-specialty day program on October 26^th. This session is attended by most of the thought leaders and specialists of retina. The selection for presentation by the sub-specialty course directors at AAO 2018 is also a recognition of the high level of interest in efforts to address a significant unmet need for advanced atrophic dry Age-related Macular Degeneration (dry-AMD) and significant potential of PRIMA wireless photovoltaic sub-retinal implant and first human experience.

The full set of 6-month interim results of the study for all 5 patients are expected by the end of 2018. This will enable the design of the protocol for the larger multi-centric European pivotal study to commence in 2019, required for the CE-mark.

Contacts

ABOUT PRIMA

PRIMA is a new generation miniaturized and totally wireless sub-retinal implant. The 2x2 millimeters wide and 30 microns thick photovoltaic chip contains 378 electrodes. Implanted under the retina via a minimally invasive surgical procedure, it acts like an array of tiny solar panel powered by pulsed near infrared light projected from a miniature projector integrated in a pair of augmented reality glasses, along with a mini-camera. PRIMA is designed to restore some vision in patients blinded by retinal dystrophies - a very significant unmet medical need. The target population includes patients with atrophic dry Age-related Macular Degeneration (dry AMD), and also Retinitis Pigmentosa (RP). In addition to a clinical trial with five atrophic dry-AMD patients in France, PRIMA is approved for five-patients study in USA.

ABOUT AGE-RELATED MACULAR DEGENERATION (AMD)

Age-related macular degeneration^[2] is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America and Europe, impacting an estimated 12 to 15 million people worldwide, and rapidly growing due to ageing population. There are two forms of advanced AMD: the wet form, affecting about~20% of AMD patients, where treatment like anti-VEGF injections slows down the disease progression, and the dry form, representing ~80% of AMD, where there is currently no curative treatment available. More than 4 million patients are afflicted with advanced dry AMD In Europe and the United States. Patients suffering from this retinal disorder gradually lose central vision (responsible for high visual acuity, required for reading and face recognition) due to loss of photoreceptors.

ABOUT PIXIUM VISION

Pixium Vision's mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision's bionic vision systems are associated with a surgical intervention and a rehabilitation period. Pixium Vision is in clinical stage with PRIMA, its sub-retinal miniature photovoltaic wireless implant system, designed 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 spanning across the prestigious Vision research institutions including Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, and Institute of Ocular Microsurgery (IMO) in Barcelona. The company is EN ISO 13485 certified and qualifies as "Entreprise Innovante" by Bpifrance.

For more information, please visit:  www.pixium-vision.com;
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Disclaimer:

This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company's Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS^® is a trademark of Pixium-Vision SA

AAO2018- eng
Oct 23, 2018