NEJM Publishes Study Demonstrating Vision Restoration with Brain-Computer Interface Retinal Implant
The New England Journal of Medicine (NEJM) published results from a clinical trial demonstrating that Science Corporation’s PRIMA brain-computer interface (BCI) retinal implant can restore functional central vision in patients blinded by geographic atrophy (GA).
The peer-reviewed study marks a major milestone in neurotechnology and ophthalmology, showing that patients implanted with PRIMA regained meaningful vision, enabling them to read letters, numbers, and words for the first time after vision loss, according to Science Corp.
“This study confirms that, for the first time, we can restore functional central vision in patients blinded by geographic atrophy,” said Frank Holz, MD, lead author of the NEJM paper, lead investigator, and Chair of the Department of Ophthalmology at the University Hospital of Bonn. “The implant represents a paradigm shift in treating late-stage AMD.”
PRIMA is a wireless subretinal photovoltaic implant combined with a pair of specialized glasses that project near-infrared light to the implant. The system effectively bypasses degenerated photoreceptors and directly stimulates the retina’s remaining cells, sending visual information to the brain. The technology builds upon pioneering work by Professor Daniel Palanker at Stanford University, a co-author of the NEJM paper.
“This breakthrough underscores our commitment to pioneering technologies that provide hope to patients in need, and which have the ability to transform lives,” said Max Hodak, founder and CEO of Science. “We are excited about the potential of PRIMA to redefine vision restoration for these patients.”
Watch the story behind the discovery: https://www.youtube.com/watch?v=J_qTLT8kJPU&feature=youtu.be
The multicenter clinical trial evaluated PRIMA in 38 patients across 17 clinical sites in five countries. The results demonstrated consistent and clinically meaningful vision restoration:
Mean improvement of 25.5 letters (equivalent to more than five lines) on the ETDRS letter chart
84% of patients regained the ability to read letters, numbers, and words, restoring functional central vision
80% of patients achieved significant prosthetic visual acuity improvements of at least logMAR 0.2 (10 ETDRS letters) at 12 months (p<0.001)
No decline was observed in patients’ existing peripheral natural vision
The implant can be safely positioned under the atrophic macula, with most adverse events resolving within two months of surgery
The Data Safety Monitoring Board (DSMB) concluded that PRIMA’s benefits outweighed surgical risks and recommended the device for European market approval. Science has already submitted its regulatory application in Europe and anticipates PRIMA could become available to patients as early as next year. In the US, the FDA approval process is underway, alongside a newly launched patient registry for macular degeneration.
A Transformational Approach to Artificial Vision
The PRIMA system consists of an ultra-thin (2 mm × 2 mm × 30 µm) wireless subretinal implant paired with specialized glasses. The glasses project near-infrared light onto the implant, which acts as a miniature solar array to convert light into electrical signals, stimulating the retinal cells that remain functional. A “zoom-in” feature enables patients to magnify text or objects.
Unlike conventional or experimental therapies—such as gene or cell-based approaches that attempt to slow disease progression—PRIMA directly restores lost functional vision, offering patients new independence and quality of life.
“It’s the first time that an attempt at vision restoration in these cases has achieved results—and in such a large number of patients,” said Prof. José-Alain Sahel, MD, senior co-author of the study from the University of Pittsburgh School of Medicine, Sorbonne Université, and Institut de la Vision, Paris. “More than 80% of patients were able to read letters and words, and some are reading pages in a book. This is something we couldn’t have dreamt of when we started this journey over a decade ago.”
Millions of people worldwide suffer from AMD. The current generation of PRIMA targets those with advanced GA and severe central vision loss, while Science said it is already developing a next-generation implant with enhanced image processing and ergonomics to expand its applicability and improve visual performance.