Pixium Vision announced that its next-generation miniaturized wireless subretinal implant, PRIMA, aimed at restoring vision in patients affected by retinal dystrophies, received authorization from the French regulatory agency, Agence Nationale de Sécurité du Médicament et des Produits de santé (ANSM), to start a feasibility clinical study in patients with advanced dry age-related macular degeneration (AMD).
“The approval of the clinical study is a significant advance for the PRIMA system, our next generation wireless sub-retinal implant system, as well as for Pixium Vision," Khalid Ishaque, Chief Executive Officer of Pixium Vision, said in a company news release. "Conceived initially by the researchers at Stanford University, and successfully developed through to clinical stage by our team at Pixium Vision in close collaboration with numerous physicians and scientists, PRIMA enters an exciting phase of its development, with a first patient expected to be implanted before year end. With aging population dynamics, advanced dry AMD is a leading cause of irreversible vision loss with currently estimated over 4 million people without approved treatment option making it a significant unmet medical need."
The clinical study entitled “Feasibility Study of Compensation for blindness with the PRIMA system in patients with dry age related macular degeneration” is designed to evaluate the tolerance of PRIMA and to demonstrate the evoked central visual perception among patients who have lost their sight due to atrophic advanced dry-AMD. The study is planned to recruit 5 patients with interim evaluation at 6-month follow-up and longer term follow-up to 36 months. The study will be conducted at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris with Dr. Yannick Le Mer, vitreoretinal surgeon and ophthalmologist, as principal investigator.
In parallel, Pixium Vision actively pursues its constructive discussions with the FDA in order to also prepare the feasibility study with PRIMA in the US.
PRIMA is a wireless miniaturized new generation implant. The PRIMA implant is a micro photovoltaic chip of 2 millimeters and 30 microns thick, and is equipped with 378 electrodes. Implanted under the retina via a less invasive surgical procedure, implant converts pulsed near infra-red invisible light signal received from the external glasses with an integrated mini-camera into electrical signals transmitted to the brain via the optic nerve. PRIMA is designed to treat retinal dystrophies, particularly aiming to treat advanced atrophic dry AMD, the most prevalent form of age-related macular degeneration, thanks to miniaturization and aimed to preserve patient’s residual peripheral vision. Prima is also intended to be evaluated at a later stage for treatment of vision loss from retinitis pigmentosa.