Pixium Vision Earns FDA Nod for Expanded Prima Feasibility Study

Bionic vision systems company Pixium Vision has earned U.S. Food and Drug Administration (FDA) approval to expand its Prima system’s U.S. feasibility study to include Stanford Medicine as a clinical site.
 
The Byers Eye Institute joins the original two locations at the UPMC Eye Center in Pittsburgh and the Bascom Palmer Eye Institute in Miami.
 
The study aims to assess Prima’s safety and performance for dry age-related macular degeneration (AMD) and will recruit five patients. Near Visual Acuity assessment will be measure at 12 months and data readout is expected next year.
 
A separate feasibility study in France demonstrated improved visual acuity in dry AMD patients using Prima, and a pivotal study is underway in several European countries.
 
“We are very pleased to be expanding the number of sites of our Prima System US feasibility study,” Lloyd Diamond, CEO of Pixium Vision told the press. “We know that the medical team is very familiar with the design of the implants and we look forward to observing the results of their procedures first hand.”