French bionic vision company Pixium Vision has received approval to start a feasibility clinical study of its wireless subretinal implant, Prima, in patients with advanced dry age-related macular degeneration (dry-AMD).
The Prima implant is a micro photovoltaic chip just 2 mm in size and 30 microns thick. It is equipped with 378 electrodes and implanted under the retina via a minimally-invasive surgical procedure.
The implant converts pulsed near infrared invisible light signal received from the external glasses with an integrated mini-camera into electrical signals transmitted to the brain via the optic nerve.
The clinical study 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 five patients with interim evaluation at a six-month follow-up and a longer term follow-up to 36 months. The study will be conducted 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,” said Pixium CEO Khalid Ishaque.
“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 ageing population dynamics, advanced dry-AMD is a leading cause of irreversible vision loss with currently estimated over four million people without approved treatment option making it a significant unmet medical need.”
DryAMD is the most prevalent form of Age-related Macular Degeneration. Prima is also intended to be evaluated at a later stage for treatment of vision loss from Retinitis Pigmentosa.
Bionic Vision Technologies (BVT) grew out of the Bionic Vision Australia project, a consortium of universities and research institutes, looking to develop prostheses to restore vision to the blind.
Like the Pixium technology, BVT uses a camera attached to a pair of glasses, an externally worn vision processing unit and an electrode array implanted behind the retina.
In April 2017, it announced it had raised $23.5 million and would soon be starting clinical trials.