Pixium Vision receives FDA

Pixium Vision receives FDA approval to begin human clinical study of its PRIMA sub-retinal implant in the US

The feasibility clinical study is designed to evaluate PRIMA in patients with Atrophic Dry Age-related Macular Degeneration

PARIS–(BUSINESS WIRE)–Regulatory News:

“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”

Pixium Vision (Paris:PIX) (FR0011950641 – PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced today that it has received the approval from the US Food and Drug Administration (FDA) to begin the clinical feasibility study for PRIMA, Pixium Vision’s 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. “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.”

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…..

Read more: https://www.businesswire.com/news/home/20180103006026/en/Pixium-Vision-receives-FDA-approval-human-clinical

Source: Business Wire