FDA approves sub-retinal implant clinical feasability study
Miniaturized wireless photovoltaic sub- retinal implant for patients with AMD
Pixium Vision has received approval from the US Food and Drug Administration (FDA) to begin the clinical feasibility study for PRIMA, a new-generation miniaturized wireless photovoltaic sub- retinal implant, in 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 Khalid Ishaque, Chief Executive Officer of Pixium Vision.
The clinical feasibility study of PRIMA implant, to be conducted at the University of Pittsburgh Medical Center, will recruit up to five patients with vision loss that results from Atrophic Dry Age-related Macular Degeneration. The primary endpoint is restoration of visual perception as well as safety at a 12-month follow-up with a longer- term follow-up duration of 36 months. Pixium Vision expects to start the US study in the first half of 2018.
PRIMA is a miniaturized new generation implant totally wireless. The PRIMA implant is a micro photovoltaic chip of 2×2 millimeters and 30 microns thick, and is 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, particularly aiming to treat initially advanced atrophic dry-AMD, 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,” said a company spokesman.