Pixium Vision announces the approval by US FDA of the expansion of the Prima System* US feasibility study to include Stanford Medicine as a clinical site.
This third location for the study at the Byers Eye Institute at Stanford Medicine joins the original two locations at the UPMC Eye Center in Pittsburgh and the Bascom Palmer Eye Institute in Miami.
The US feasibility study aims to evaluate the safety and performance of the Prima System in patients with dry AMD and will recruit 5 patients. The primary endpoint is Near Visual Acuity assessment measured at 12 months. Data readout is expected in 2023. A separate feasibility study conducted in France showed improved visual acuity in patients with dry AMD with use of the Prima System. A pivotal study of the Prima System is underway in several European countries.
Pixium licensed technology from Stanford University.
“We are very pleased to be expanding the number of sites of our Prima System US feasibility study,” said Lloyd Diamond, Chief Executive Officer of Pixium Vision. “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.”
* CAUTION – Investigational device. Limited by United States law to investigational use.