PRIMA retinal implant receives CE mark for vision restoration in geographic atrophy

The photovoltaic implant and specialized glasses restored functional central vision in a clinical study of patients with profound vision loss from geographic atrophy secondary to age-related macular degeneration.

Science Corporation has received CE marking for the PRIMA retinal implant system, enabling its commercial availability across 30 European countries for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).¹ The first commercial implantation is expected in Germany, while reimbursement applications and clinical site activation are underway across Europe.

Don’t miss out on hearing about our latest peer-reviewed articles, expert opinions, conference news, podcasts and more.

Register Register

PRIMA combines a 2 × 2 mm wireless photovoltaic chip, surgically implanted beneath the atrophic macula, with camera-equipped glasses and a pocket processor. The glasses capture images and project them onto the implant using near-infrared light. Photovoltaic pixels convert the light into electrical signals that stimulate surviving retinal neurons, creating prosthetic central vision. The system includes a magnification function to support activities such as reading.

Evidence supporting the device included an open-label, prospective, single-group study involving 38 patients treated at 17 centers across five European countries. Participants had bilateral GA involving the fovea and profound central vision loss in the study eye.

At 12 months, patients achieved a mean improvement of 25.5 Early Treatment Diabetic Retinopathy Study letters – equivalent to more than five lines– when using prosthetic vision. Among participants completing the assessment, 80% improved by at least 0.2 logMAR, or approximately 10 letters, and 84% reported using the system to read letters, numbers, or words. Implantation beneath the atrophic retina was not associated with a reduction in mean residual natural peripheral vision.²

The findings should be interpreted in the context of the study’s small size and uncontrolled design. The system also provides limited, monochromatic vision rather than restoring normal sight. Nevertheless, the ability to recover detailed form vision represents a notable advance for people with severe central vision loss, as currently approved pharmacologic treatments for GA aim to slow lesion progression rather than restore vision that has already been lost.

PRIMA has received Breakthrough Device designation and two Humanitarian Use Device designations from the FDA including one covering an advanced subset of bilateral GA-related blindness.³ A Humanitarian Device Exemption would still be required before the system could be marketed in the USA.

References

1. Science Corporation. Science Corp. announces European commercial launch of PRIMA. Published July 22, 2026. Available at: https://science.xyz/news/ce-mark/ (accessed July 24, 2026).
2. Holz FG, et al. Subretinal photovoltaic implant to restore vision in geographic atrophy due to AMD. N Engl J Med. 2026;394:232–42.
3. Science Corporation. PRIMA receives Humanitarian Use Device designations from the US Food and Drug Administration. Published July 22, 2026. Available at: https://science.xyz/news/hud-designation (accessed July 24, 2026).