Paris-based technology company Pixium Vision announced today that it has received approval from the FDA to begin the clinical feasibility study for its newly developed retinal implant. Called PRIMA, the device is a new-generation miniaturized wireless photovoltaic subretinal implant for patients with Atrophic Dry Age-related Macular Degeneration (AMD).
“This first approval in the US will allow Pixium Vision to commence a feasibility study of the PRIMA device and follows a thorough review by the FDA. It also highlights the FDA’s recognition of PRIMA’s innovative potential to address the significant unmet need to treat Atrophic Dry-AMD,” said Pixium Vision CEO Khalid Ishaque.
“Atrophic Dry-AMD is a major cause of irreversible loss of the vision which affects approximately 4 million people and for whom there is currently no proven therapeutic solution. Alongside the ongoing clinical trial in France, the feasibility study in the United States marks a significant milestone for Pixium Vision with the mission to create a world of bionic vision for those who have lost their sight.”
The completely wireless PRIMA implant is a 2x2-millimeter microchip with 30 microns of thickness equipped with 378 electrodes. Implanted under the retina via a less invasive surgical procedure, the implant converts pulsed near infra-red 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 and preserve the patient’s residual peripheral vision.
The PRIMA clinical feasibility study will be conducted at the University of Pittsburgh Medical Center and will recruit up to five patients with vision loss resulting from Dry-AMD. The primary endpoint is restoration of visual perception as well as safety at a 12-month follow-up and a longer term follow-up duration of 36 months. Pixium Vision expects to commence this study in the first half of 2018.
Read the full press release from Pixium Vision.