This article is more than 5 years old. Information may no longer be current.
First human trial of PRIMA subretinal implant approved
Click Here to Manage Email Alerts
The PRIMA miniaturized, wireless, subretinal implant to restore vision in patients affected by retinal dystrophies has received French authorization to begin a feasibility study in human patients with advanced dry age-related macular degeneration, according to a Pixium Vision press release.
The study, which will enroll five patients, was approved by the French regulatory agency Agence Nationale de Sécurité du Médicament et des Produits de Santé. It will evaluate the tolerance of PRIMA and demonstrate the central visual perception in patients who have lost sight due to dry AMD. It will be led by Yannick Le Mer, MD, and take place at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris.
“The approval of the clinical study is a significant advance for the PRIMA system, our next generation wireless subretinal implant system, as well as for Pixium Vision,” Khalid Ishaque, Pixium’s CEO, said in the 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.”
Pixium is also pursuing discussions with the FDA regarding a PRIMA feasibility study in the United States.