- Data confirm better than expected interim six-month results
- The system is sustainably well tolerated while preserving residual peripheral vision
- Some patients improve their ability to identify letters and sequence of letters
Paris, July 18, 2019 – 07:00 AM 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 sustained positive data at 12 months from the first feasibility study of its PRIMA System in Age-related Macular Degeneration (AMD) patients, confirming the better than expected 6-month interim results.
The 12-month data, after implantation and rehabilitation for five patients in France with advanced dry AMD (geographic atrophy), demonstrated that the PRIMA System met the primary endpoint which showed the successful elicitation of light perception in the central retinal area in all subjects measured by the Octopus test. None of the patients had remaining central visual activity at enrolment. Patients had visual rehabilitation, and, at 12-months, most can identify letters with some able to identify sequence of letters and demonstrating increasing speed over time. There were no device-related serious adverse events.
Lloyd Diamond, Chief Executive Officer stated: “We are pleased to have confirmed the durability of the better than expected outcome in our 6-month interim results in this 12-month data set. The fact that patients were able to not only re-establish light perception but also identify letters suggests that the PRIMA System may soon afford patients life changing improvements in quality of life. To this end, we are working to optimize development of the Prima System and have opened a second investigational center for our U.S. feasibility study, the Bascom Palmer Eye Institute in Miami, Florida, one of the highest ranked U.S. ophthalmology centers. We also continue to engage with regulators in U.S. and Europe to pursue the best path for regulatory approval.”
Prima System is designed to restore sight in patients blinded by retinal dystrophies – a very significant unmet medical need. It features a miniaturized and totally wireless sub-retinal implant and augmented reality glasses. The 2x2 millimeter wide, 30-micron thick photovoltaic chip contains 378 electrodes. Implanted under the retina via a minimally invasive surgical procedure, it acts like an array of a tiny solar panel powered by pulsed near infrared light projected from a miniature projector transmitting images captured on a mini camera. The camera and projector technologies are integrated into augmented reality glasses, which together with the implant, make the Prima System. The target populations includes patients with atrophic dry Age-related Macular Degeneration (dry AMD) and Retinitis Pigmentosa (RP). In addition to a clinical trial in five atrophic dry-AMD patients in France, Prima System also is authorized for clinical testing in a similar five-patient feasibility study in U.S.
Age-related macular degeneration is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America and Europe. The global impact is significant with current projected estimates for people living with AMD of around 196 million people worldwide and expected rapid growth due to ageing population. Around 1,000 new patients are diagnosed everyday in Europe and U.S. There are two forms of advanced AMD: the wet form, where treatment like anti-VEGF injections slows down the disease progression, and the dry form that is most frequent, where there is currently no curative treatment available. More than 5 million patients are afflicted with advanced dry AMD, also referred to as Geographic Atrophy. Patients suffering from this retinal dystrophy gradually lose their central vision (responsible for high visual acuity, e.g. for reading and face recognition) due to the loss of photoreceptors.
Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing 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, including some of the most prestigious vision research institutions in the world, such as: Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
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