Image Credit: AI Generated Image  |  Prima vision implant

The Prima vision implant is intended for patients whose central vision loss has affected reading, face recognition and daily independence. Geographic atrophy linked to AMD affects millions of people globally and destroys photoreceptors in the central retina, leaving patients with severe central blind spots while peripheral vision may remain.

The device uses a thin subretinal photovoltaic implant placed beneath the atrophic macula. A pair of special glasses projects near-infrared light onto the implant, which converts that light into electrical stimulation signals for the retina.

The system also includes magnification for letter recognition and wireless operation. Science Corporation’s patient-facing material describes Prima as a two-part system: a small device placed under the retina where light-sensing cells have been lost, and glasses that send visual data and power through patterned light.

Trial Data Supports CE Mark Vision Restoration

Science Corporation evaluated the Prima system in a multicenter study involving 38 participants at 17 clinical sites across five countries. The company reported an average improvement of 25.5 letters, or more than five lines, on the ETDRS letter chart.

In the study, 84% of patients regained the ability to read letters, numbers and words. Another 80% recorded gains of at least logMAR 0.2, equivalent to 10 letters, after 12 months, with statistical significance reported at p < 0.001.

The company also said the implant procedure, which places the photovoltaic retinal chip under the atrophic macula, did not result in a decline in mean natural vision. That finding is important for patients who may still rely on remaining peripheral sight.

The PRIMAvera trial results have become central to the company’s European launch plan. The technology is being positioned as a treatment option for patients with advanced atrophic dry AMD where existing care options remain limited.

How the Prima System Works

The Prima system does not restore normal biological vision. It creates an artificial vision pathway using a subretinal photovoltaic implant and external glasses. The glasses capture and process visual information, then project near-infrared patterns onto the implanted chip. The chip converts those signals into electrical stimulation, which activates surviving retinal neurons and sends visual information toward the brain.

That makes the technology part retinal implant and part BCI technology. It is designed to restore central visual function for tasks such as reading, rather than fully recreating natural sight.

A report on the approval noted that the current version provides black-and-white vision in a limited central field. Even with that limitation, the results mark a major step for vision restoration in advanced AMD patients.

Key reported elements of the system include:

  • A thin subretinal photovoltaic implant
  • Glasses that project near-infrared light
  • Wireless integration between glasses and implant
  • Magnification support for letter recognition
  • Use in geographic atrophy due to age related macular degeneration

European Launch Begins as US Talks Continue

The CE mark allows Science Corporation to start the Prima BCI European rollout while reimbursement processes continue country by country. Germany is expected to host the first commercial surgical implantation.

The approval also places the company within a growing field of medical device regulation for neurotechnology and retinal prosthetics. The EU Medical Device Regulation requires devices to meet safety and performance requirements before market access.

In the United States, Science Corporation is in discussions with the Food and Drug Administration on market access. Prima has received breakthrough device and humanitarian use device designations, which are intended for technologies addressing serious or rare conditions with limited treatment options.

Science Corporation acquired intellectual property and related assets for the Prima retinal implant from French bioelectronics company Pixium Vision in April 2024. The acquisition gave the company control of a device already supported by years of clinical and regulatory development.

The European launch now moves Prima from trial-stage promise into commercial medical use. For patients with advanced AMD-related geographic atrophy, the rollout offers a new route to restoring limited functional central vision while also testing how BCI-linked retinal implants will fit into everyday clinical care, reimbursement systems and long-term vision treatment.

This story was originally featured in the Medical Device