Pixium’s Prima System Gets Breakthrough Device Status

The FDA has granted Pixium Vision Breakthrough Device status for its Prima System, an investigational device for restoring partial vision for people with blindness caused by dry age-related macular degeneration (AMD).

The company’s photovoltaic substitute for photoreceptors — a miniature wireless eye implant — allows simultaneous use of the implant’s central prosthetic vision and the patient’s peripheral natural vision.

The system is “making great progress in the clinic with a read-out on the primary endpoints due toward the end of this year,” said Pixium CEO Lloyd Diamond, adding that the company expects to use the data to start discussions with European regulators and to support its U.S. regulatory submission.

The primary endpoint is a significant improvement in visual acuity over baseline. The study will include three years of follow-up with an assessment of the primary endpoints 12 months after implantation.

Related Topics