PRIMA Retinal Implant Approved in EU, Restores Vision in AMD
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- Science Corporation's PRIMA implant received CE certification under the EU Medical Device Regulation, enabling its use in the European Union and the UK — the first such approval for a retinal prosthesis that lets people with severe vision loss read letters, numbers, and words.
- The pinhead-sized device is implanted beneath the retina and paired with glasses carrying a frame-mounted camera that projects processed images onto the implant's chips via near-infrared light, stimulating bipolar cells that are typically spared by macular degeneration.
- In a study published in October last year, PRIMA restored central vision and improved visual acuity in roughly 80% of cases, with patients reaching about 20/160 vision — moving them from legally blind to not blind, according to researcher Frank Brodie.
- Geographic atrophy, which affects approximately 8 million people worldwide, currently has only two FDA-approved medicines in the US — both injected into the eye — that slow disease progression but cannot recover lost vision, said Sunir Garg of Wills Eye Hospital.
- PRIMA has also received Breakthrough Device and Humanitarian Use Device designations from the FDA, which Science Corporation calls an important pathway toward US approval.
- The first commercial procedures are planned soon in Germany, where sites and surgeons have already been selected, with UK rollout expected later this year.
- The glasses are powered by light itself — similar to solar panels — eliminating the need for a tethered power source, said Darius Shahida of Science Corporation.
- Researchers are exploring the implant's potential for other macula-affecting conditions such as Stargardt disease, Brodie noted.
Why it matters: For the roughly 8 million people worldwide with geographic atrophy, two FDA-approved drugs can only slow the disease — PRIMA is the first approved technology that actually restores lost central vision, and its EU/UK launch later this year will be the first real-world test of whether the 80% efficacy seen in a small trial holds at scale.
