•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, CEST -Pixium Vision (FR0011950641 -PIX), a bio electronics company developing innovative bionic vision systems to enable patients who have lost their sight to more independent lives, announced sustained positive data at 12 months from the first feasibility studyof 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 end point 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 Officerstated: “We are pleased tohaveconfirmedthedurability of thebetter than expected outcome in our6-month interim results inthis 12-month data set.The fact that patients were able tonot only re-establish light perception but alsoidentify letters suggests that the PRIMASystem may soon afford patientslife changingimprovements in quality of life. To this end, we are workingto optimizedevelopmentof the Prima System and haveopeneda second investigational centerfor our U.S. feasibility study, the Bascom Palmer Eye Institute in Miami, Florida, one of the highest ranked U.S. ophthalmology centers.We alsocontinue toengage with regulators in U.S. and Europeto pursue the best path for regulatory approval.”
Prima Systemis 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 2×2 millimeter wide, 30-micronthick 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 the US.
Age-related macular degeneration is the 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 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.
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