PRIMA, a pinhead sized sub retinal chip paired with camera glasses, won a CE mark for geographic atrophy, the advanced stage of dry AMD that affects about 8 million people worldwide.
Europe has become the first regulator in the world to approve a device that gives people with a previously untreatable form of blindness a working form of reading vision.
The device, PRIMA, is a pinhead-sized chip implanted under the retina and paired with camera-equipped glasses. It won a CE mark this week for geographic atrophy, an advanced, irreversible form of dry age-related macular degeneration that affects roughly 8 million people worldwide.
A frame-mounted camera captures the scene; the glasses project it as near-infrared light onto the chip beneath the damaged rod and cone cells. The chip stimulates the still-healthy bipolar cells underneath, which the brain learns to interpret as a rough form of central vision. The glasses are powered by incident light, so there is no tethered battery.
Independent clinician Sunir Garg of Wills Eye Hospital in Philadelphia called it an "impressive achievement" but drew a line at cure. The two existing FDA-approved geographic atrophy drugs only slow progression; PRIMA is restorative, though it produces prosthetic rather than natural vision, and only works where bipolar cells remain intact. US approval and reimbursement are still pending.