PARIS--(BUSINESS WIRE)--Regulatory News:
Pixium Vision (Paris:PIX) (FR0011950641 - PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announces successful activations of PRIMA, its new generation miniature wireless photovoltaic sub-retinal implant, in the first 3 patients with severe vision loss from atrophic dry Age-related Macular Degeneration (AMD), out of the 5 planned in the French feasibility study started in December 2017.
The initial observations are encouraging only few weeks following the first implantations:
- In all 3 patients, the miniature wireless chips were successfully implanted under the atrophic macula via a minimal invasive surgical procedure, and the chip placement is stable throughout the postoperative follow-up period,
- All 3 patients perceive light patterns, within the expected ranges of light intensity, in the area where no light perception remained previously due to loss of light-sensitive cells. Resolution of the perceived signal matches the expectations.
As planned by the clinical protocol, patients are undergoing training and readaptation.
Khalid Ishaque, Chief Executive Officer of Pixium Vision, stated: “Following activation of the implants in the first 3 patients, the initial observations are exciting for the Company. They confirm PRIMA’s ability to restore light perception from the retinal atrophic zone of these dry-AMD patients, where no visual sensitivity remained prior to the treatment. This is in line with the expectations based on preclinical experiments. The feasibility studies will advance with 2 more patients to be recruited in Paris, and additional 5 patients in the US feasibility trial which is to begin shortly. We are confident that PRIMA is a feasible therapeutic option to restore some useful vision in patients blinded by retinal degeneration.”
The French feasibility study1 with PRIMA is a 36-month, 5-patient clinical study, designed to evaluate the safety and function of the wireless sub-retinal PRIMA chip in eliciting visual light perception, with an interim 6-month analysis enabling to prepare and start also for the pivotal clinical study in EU.
PRIMA is a new generation miniaturized and totally wireless sub-retinal implant. The PRIMA implant is a micro photovoltaic chip of 2x2 millimeters and 30 microns thick, equipped with 378 electrodes. Implanted under the retina via a less invasive surgical procedure, it acts like a tiny solar panel that is powered by pulsed near infrared light through a miniaturized projector integrated in a pair of augmented reality-like glasses, along with a mini-camera, worn by the implanted subject. PRIMA is designed to compensate for severe vision loss from retinal dystrophies, initially atrophic dry Age-related Macular Degeneration (dry AMD), a significant unmet medical need with currently no curative therapeutic solution, and at later stage also Retinitis Pigmentosa (RP).
ABOUT AGE-RELATED MACULAR DEGENERATION (AMD)
Age-related macular degeneration2 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 which is continuously growing due to ageing population. There are two forms of AMD, the wet form, representing ~20% of AMD, where treatment like anti-VEGF injections is available slow 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 start by losing their central vision (responsible for visual precision and details, for example, required for reading and face recognition) and progressively become blind.
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 as well as a rehabilitation period. Following the CE mark for its first bionic retinal implant systems, IRIS®II, Pixium Vision is now conducting a clinical study1 in Human with PRIMA, its new generation sub-retinal miniaturized photovoltaic wireless implant system, 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 the Institut de la Vision in Paris, the Stanford University in California, 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” par Bpifrance.
Pixium Vision is listed on Euronext Paris (Compartment C). Pixium Vision shares are eligible for the French tax incentivized PEA-PME and FCPI investment vehicles.
Pixium Vision is included in the Euronext CAC All Shares index
Euronext ticker: PIX - ISIN: FR0011950641 – Reuters: PIX.PA – Bloomberg: PIX:FP
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
1 Feasibility 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