The PRIMA retinal implant receives the CE mark for geographic atrophy due to macular degeneration

What happened

Science Corporation announced on 22 July 2026 the European commercial launch of PRIMA, after the system received the CE mark under the EU Medical Device Regulation from DEKRA. The approval allows it to be marketed in 30 European countries. According to the company, PRIMA is the first brain-computer interface device with a CE mark for restoring form vision, meaning the ability to read letters, numbers and words.

Geographic atrophy, linked to age-related macular degeneration, gradually destroys the photoreceptors at the centre of the retina and affects more than five million people worldwide. PRIMA is a 2 x 2 mm photovoltaic implant placed under the retina that works with special glasses: they project near-infrared light onto the implant, which converts it into electrical stimulation of the remaining retinal cells. The technology was originally developed by Prof. Daniel Palanker at Stanford University.

What the data show

The pivotal PRIMAvera study, published in the New England Journal of Medicine (online from 20 October 2025), included 38 patients at 17 centres in five European countries. Of the 32 assessed at 12 months, 26 (81%) had a clinically meaningful improvement in visual acuity. There were 26 serious adverse events in 19 participants; most occurred within two months of surgery and nearly all of those resolved within two months. Natural peripheral vision remained at its pre-implant level.

The 36-month data were presented at the EURETINA congress in Vienna and announced by the company on 5 October 2026: no new safety concerns emerged between months 12 and 36, and the mean improvement was 29 letters on the visual acuity chart. At this point, only 18 patients could be assessed for efficacy.

What it means for patients now

PRIMA is intended for a subset of patients with advanced geographic atrophy and severe loss of central vision. Implantation requires surgery under the retina, and the restored vision is used through the special glasses, which also have a zoom function. The company said the first commercial implant was expected in Germany and that reimbursement applications are under way country by country; actual access depends on those decisions. In the US, the device is still awaiting FDA approval.

What is still unknown

The long-term data come from a small number of patients, and results beyond three years are not yet available. It is not yet known in which countries and on what terms the implant will be reimbursed, or how quickly centres able to implant it will be in place. The company is working on a new version with higher resolution and a wider field of view, which is not yet available.