Pixium Vision announced that it has received approval from the FDA to begin the clinical feasibility study for PRIMA, Pixium Vision’s new-generation miniaturized wireless photovoltaic subretinal 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,” Khalid Ishaque, Chief Executive Officer of Pixium Vision, said in a company news release. “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 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.