PRIMA Retinal Implant Launched in EU

In our top stories, Science Corporation announced the European commercial launch of Prima, a brain-computer interface-based retinal implant for patients with geographic atrophy secondary to AMD.

Prima consists of a subretinal photovoltaic implant used in conjunction with specialized glasses.

The glasses project near-infrared light onto the implanted device, which converts the light into electrical stimulation of retinal cells.

The system also includes a zoom function that allows patients to magnify text.

Science says Prima is the first and only treatment to demonstrate restoration of functional central vision in patients with GA due to AMD in clinical trials.

It is also the first brain-computer interface device to receive CE marking for restoring detailed form vision, including the ability to read letters, numbers, and words.

Results from the multicenter study were recently published in the New England Journal of Medicine.

The trial of 38 patients showed patients experienced a mean improvement of more than five lines on the visual acuity chart, and 84% of participants reported the ability to read letters, numbers, and words following implantation.

About 80% achieved improvements of at least 0.2 logmar at 12 months.

The Prima device received CE mark under the European Union medical device regulation from Decra, allowing commercial distribution across 30 European countries.

The company has begun country-specific reimbursement applications and clinical site activations across Europe, with the first commercial implantation expected in Germany.

In the United States, Science is working with the FDA toward commercialization.