Pixium Vision has received approval from the FDA to begin a clinical feasibility study for Prima, a miniaturized wireless photovoltaic subretinal implant, for the treatment of atrophic dry age-related macular degeneration.
The study will be conducted at the University of Pittsburgh Medical Center and will recruit up to five patients with vision loss from atrophic dry AMD. The primary endpoint is restoration of visual perception as well as safety at 12 months, with a longer-term follow-up of 36 months. The study is expected to start in the first half of the year, according to a company press release.
“This first approval in the U.S. 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,” Khalid Ishaque, CEO of Pixium Vision, said in the release.
The implant is a micro photovoltaic chip equipped with 378 electrodes that is implanted under the retina. It converts pulsed near infrared light signal received from external glasses with a mini-camera into electrical signals sent to the brain via the optic nerve, according to the release.