Pixium Vision reports positive data with PRIMA, its wireless retinal implant, at the Annual Meeting of the
American Academy of Ophthalmology

Paris, France. October 30, 2018 - 7.00 AM CET - 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, announces positive latest clinical data from the feasibility trial[1] of PRIMA in France, reported by Professor José A. Sahel during the Annual Meeting of American Academy of Ophthalmology (AAO 2018), held in Chicago (USA).

Prof. Daniel Palanker, Department of Ophthalmology at Stanford University, inventor of PRIMA chip, highlighted: "We are happy to witness the remarkable success of the PRIMA chip in providing prosthetic vision to dry-AMD patients. The feasibility study in France is still ongoing, but we already see that photovoltaic restoration of central vision is possible with resolution close to the expected performance with the current pixel size. As we continue our research and development of smaller pixels, we are looking forward to providing even higher resolution for more functional restoration of sight."

The latest clinical dataset with the PRIMA implant, a miniature wireless photovoltaic sub-retinal chip, demonstrated safety of the implantation procedure in patients with atrophic dry Age-related Macular Degeneration (AMD). The implant remains stable under the retina, and the procedure did not affect the residual peripheral vision. During the training and rehabilitation follow-up in France, a majority of the patients afflicted with atrophic Dry-AMD are able to correctly identify different visual patterns, including letters and numbers. These data exceeded the initial expectations and endpoints of the trial.

The positive first results reported from the study in France provides confidence for reproducing the results also from the US early feasibility study active at UPMC Pittsburgh, the single US study centre.

Prof. 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) commented: "The wireless photovoltaic chip PRIMA enabled patients afflicted with atrophic Dry-AMD to identify correctly different visual patterns including letters. We continue the visual rehabilitation programs for implanted patients in Paris including the training for reading. We expect this positive clinical experience to increase awareness in the USA and attract even more candidates for the PRIMA feasibility study[2] in Pittsburgh."

The full set of 6-month results of the study conducted in France are expected by the end of 2018 and they will guide the design of the protocol for a larger multi-center European pivotal study to commence in 2019, required for the CE-mark.


Contacts

Pixium Vision

 

Didier Laurens, CFO
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US Investor Relations
ICR
David Clair
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+1 646 277 12 66

 

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 into augmented reality glasses, along with a mini-camera. PRIMA is designed to restore sight 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 a similar five-patients study in USA.

ABOUT AGE-RELATED MACULAR DEGENERATION (AMD)

Age-related macular degeneration[3] 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, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as "Entreprise Innovante" by Bpifrance.


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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).
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[1] Study of Compensation for Blindness with the PRIMA System in Patients with Dry Age-Related Macular Degeneration (PRIMA FS) https://www.clinicaltrials.gov/ct2/show/NCT03333954

[2] Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Atrophic Dry Age Related Macular Degeneration (PRIMA-FS-US) https://clinicaltrials.gov/ct2/show/NCT03392324

[3] http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30393-5/fulltext


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