Science Corp's PRIMA Implant Becomes First Device to Restore Vision Lost to Macular Degeneration
CE-certified retinal prosthesis enables patients to read and recognize faces in breakthrough for geographic atrophy treatment.
Science Corporation has received CE certification under the European Union Medical Device Regulation for its PRIMA retinal implant, marking the first time a brain-computer interface device has been approved to restore functional vision lost to age-related macular degeneration.
The certification, issued by DEKRA in July 2026, clears the system for commercial launch across 30 European countries, with Germany leading the rollout. The device targets geographic atrophy, a severe form of dry AMD that affects approximately 5 to 8 million people worldwide and currently has no approved treatment capable of restoring lost vision.
How PRIMA Works
The system consists of a 2x2mm photovoltaic implant placed beneath the retina and specialized glasses equipped with a camera and near-infrared projector. The glasses project near-infrared light onto the implant, which converts it into electrical signals that stimulate bipolar cells in the retina, bypassing damaged rod and cone cells.
The implant itself is light-powered, receiving wireless energy from the glasses rather than requiring tethered connections or internal batteries. This design enables patients to use the device during normal daily activities without cumbersome external equipment.
Clinical Results
In a 38-patient study published in the New England Journal of Medicine, 84% of participants could read letters, numbers, and words after receiving the implant. Eighty percent achieved meaningful visual acuity improvement, with a mean gain of 25.5 ETDRS letters—approximately five lines on a standard eye chart.
"We've had patients who could recognise the face of the Queen and others who've drawn the Sydney Opera House through the device," said Darius Shaha of Science Corporation.
Sunir Garg of Wills Eye Hospital called the PRIMA implant "an impressive achievement," noting that existing FDA-approved medications for geographic atrophy "slow down the progressive disease, but unfortunately, cannot bring back lost vision."
Regulatory Pathway and Funding
The device has received both Breakthrough Device and Humanitarian Use Device designations from the US FDA, with two separate HUDs granted—one for advanced geographic atrophy and another for Stargardt disease, a related inherited retinal condition. US approval remains pending.
Science Corporation raised $230 million in Series C funding in March 2026, bringing total funding to approximately $489 million. The capital will support European commercialization and ongoing US regulatory efforts.
What This Means for Patients
Geographic atrophy involves the progressive, irreversible deterioration of the macula as retinal cells die. Until now, treatment options could only slow disease progression. PRIMA represents the first therapeutic pathway that actually restores functional central vision, enabling patients to perform essential tasks like reading and recognizing faces.
The technology may eventually be adapted for other retinal degenerative conditions beyond geographic atrophy, potentially expanding its impact to additional patient populations suffering from vision loss.