Pixium Vision (EPA:PIX) said today it won FDA approval to launch a clinical feasibility trial of its Prima next-gen miniaturized wireless photovoltaic sub-retinal implant designed to treat patients with atrophic dry age-related macular degeneration.
The trial of the device, which is slated to be conducted at the University of Pittsburgh Medical Center, aims ot recruit 5 patients with vision loss due to atrophic dry age-related macular degeneration, the Paris-based company said.
The study’s primary endpoint will be the restoration of visual perception and safety at 12-months, with a longer-term follow up at three years. Pixium said it expects to start the study during the first half of this year.
“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. Atrophic Dry-AMD is a major cause of irreversible loss1 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,” CEO Khalid Ishaque said in a press release.
Last October, Pixium Vision said it won approval from France’s regulatory agency to launch a feasibility clinical study of its Prima sub-retinal implant.