The French bioelectronics company Pixium Vision has reported that its PRIMA bionic vision system has restored some central vision in patients with advanced dry age-related macular degeneration (AMD) participating in a clinical feasibility trial. Led by Dr. Yannick Le Mer, the study took place in the Department of Pr. José Sahel, Hopital des Quinze Vingts and Fondation Ophtalmologique A. De Rothschild, in Paris, France.
At six months, a majority of patients, all of whom had no central vision upon trial enrollment, were able to identify complex patterns, numbers, or letters. Their speed and accuracy in identifying the visual information improved with rehabilitation. The system was safe and well-tolerated.
The company also reported that visual acuity for patients in the study measured up to 20/460, which is the highest visual acuity published to date for current retinal bionic or prosthetic technologies.
The PRIMA system includes a minimally invasive wireless microchip, which is 2×2 millimeter in size and comprised of 378 electrodes. The microchip is placed underneath the central retina, and works like a self-powered solar panel, receiving energy and images sent by a near-infrared signal transmitted from a pair of glasses. The technology was developed by Daniel Palanker, PhD, at Stanford University, with preclinical development support from the Paris Vision Institute.
Pixium Vision is planning to move the PRIMA system into a pivotal, multicenter clinical trial in Europe. After receiving authorization from the U.S. Food and Drug Administration, the company will conduct a clinical feasibility trial of the system at the University of Pittsburgh Medical Center.
The PRIMA system will be tested in people with retinitis pigmentosa (RP) at a later date.
“We are very pleased to see Pixium’s PRIMA bionic vision system perform well in an early-stage clinical trial. The degree of vision restoration at this juncture is impressive,” says Stephen Rose, PhD, chief scientific officer at the Foundation Fighting Blindness. “The PRIMA system holds promise for restoring meaningful vision to people with the most advanced vision loss.”