PRIMA, first brain-computer interface, commercially available in Europe to restore central vision in GA

Science Corporation announced in a press release the commercial launch of PRIMA in Europe. PRIMA is the first brain-computer interface (BCI) approved for form vision restoration (reading letters, numbers, words) in patients with geographic atrophy (GA) secondary to age-related macular degeneration.

PRIMA received a CE mark under the European Union Medical Device Regulation from Deutscher Kraftfahrzeug-Überwachungs-Verein e.V, which authorized its commercial availability in 30 European countries, according to the press release, and the first commercial implants are expected soon in Germany. The US FDA review is ongoing.

The lead study investigator, Frank Holz, MD, Chair of the Department of Ophthalmology at the University Hospital of Bonn, Germany, commented. “The CE marking is an exciting moment, making PRIMA commercially available to patients. It has been demonstrated in clinical trials that with PRIMA, we can restore functional central vision in patients blinded by GA. These patients, who had lost their central vision completely, have had it restored and can read letters, numbers, and words.”

PRIMA is described in the press release as a novel subretinal photovoltaic implant paired with glasses that project near-infrared light onto it, converting it to electrical stimulation. The system includes a zoom-in magnification feature that allows patients to magnify letters, an ultra-thin profile, and wireless design.

Clinical basis of approval

The multi-center clinical trial results and an accompanying editorial were published in the New England Journal of Medicine.¹ NEJM (with accompanying editorial). The study included 38 patients from 17 sites in five countries.

The key outcomes were as follows:
• an improvement in the mean Early Treatment Diabetic Retinopathy Study (ETDRS) vision of 25.5 letters, which is over five lines of vision;

• 84% of patients regained the ability to read letters, numbers, and words;

• 80% achieved an improvement in the logarithm of the minimum angle of resolution vision of 0.2 or more, equal to 10 or more ETDRS letters at 12 months (p < .001);

• and there was no decline in the existing natural vision, with the implant placed subretinally beneath the atrophic macula.

Science Corporation reported raising about $490 million in total capital (much of it for the commercialization of PRIMA), which established the company as one of the best-capitalized in the sector.

Max Hodak, CEO and co-founder of Science Corporation, said, “We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision. For decades, losing central vision to this disease meant losing the ability to read, recognize faces, and ultimately losing independence. There was no viable treatment. Now there is. We intend to make access to PRIMA real and reimbursable, as quickly as possible.”

Additional information about PRIMA is available at science.xyz/prima.

Reference

1. Holz FG, Le Mer Y, Muqit MMK, et al. Vision restoration with the PRIMA system in geographic atrophy due to AMD. N Engl J Med. 2025;394:232–42. doi: 10.1056/NEJMoa2501396