Study data indicate Science Corp.’s PRIMA brain computer interface (BCI) retinal implant restored functional central vision to a majority of patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD). A peer-reviewed original paper in the New England Journal of Medicine showed that 80% of AMD patients experienced meaningful improvement in visual acuity and could read letters, numbers, and words.

Comprised of a small light-powered retinal implant and a special pair of glasses that provide wireless power and data to the implant, the PRIMA device is based on work originally conducted by Professor Daniel Palanker at Stanford University, a co-author of the paper. Age-related macular degeneration is a leading cause of blindness that affects more than 5 million people worldwide.

“This breakthrough underscores our commitment to pioneering technologies that provide hope to patients in need, and which have the ability to transform lives,” Science Corp. Founder/CEO 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:

Study Highlights

The multi-center clinical trial evaluated the PRIMA implant system in 38 patients at 17 clinical sites in five countries. The key findings include:

• Mean improvement of 25.5 letters (more than five lines) on ETDRS letter chart.
• EIghty-four percent of patients reported the ability to read letters, numbers, and words, restoring functional central vision.
• Eighty percent of patients achieved significant prosthetic visual acuity improvements of at least logMAR 0.2 (equivalent to – 10 letters on ETDRS chart) at 12 months (p<0.001).
• No significant decline in mean existing peripheral natural vision was observed.
• The implant can be safely implanted under the atrophic macula. “Serious adverse events” occurred primarily within the first two months post-implantation and 95% of these resolved within two months.

“This study confirms that, for the first time, we can restore functional central vision in patients blinded by geographic atrophy,” said Dr. Frank Holz, lead NEJM paper author, 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.”

The Data Safety Monitoring Board for the study recommended PRIMA for European market approval, finding the benefits to patients outweighed the risk of the surgery. In Europe, the company has applied for regulatory approval and hopes to make PRIMA available to patients next year. U.S. Food and Drug Administration approval process currently is underway.

A Transformational Approach to Vision Restoration

The PRIMA implant is a subretinal photovoltaic implant paired with specialized glasses that project near-infrared light to the implant, which acts like a miniature solar panel. A zoom feature allows patients to magnify letters. The implant rests within the retina’s atrophied area and measures 2mm x 2mm x 30µm. With its ultra-thin profile and seamless, wireless integration, PRIMA offers a solution to those affected by central vision loss, according to Science Corp.

GA is characterized by a loss of photoreceptors in the retina. PRIMA combats this loss with its wireless subretinal implant that operates as an array of artificial photoreceptors, stimulating the remaining cells to carry the visual signal to the brain. Unlike conventional therapies that attempt to slow disease progression, PRIMA directly restores lost functional vision in GA patients.

“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. More than 80% of the patients were able to read letters and words, and some of them are reading pages in a book. This is really something we couldn’t have dreamt of when we started on this journey together with Professor Palanker more than a decade ago,” said Prof. José-Alain Sahel, M.D, the paper’s senior co-author from the Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh; Sorbonne Université, Paris; and Institut de la Vision, Paris.

Millions of people suffer from AMD; this generation of PRIMA can treat a subset with advanced GA where vision loss is severe. Science Corp. is developing another version of the implant and glasses that will optimize visual performance further with digital image processing and streamlined ergonomics to bring this technology to more patients.

“GA is one of the leading causes of vision loss, and before today, there was nothing which restores that lost vision,” explained Mahi Muqit, Ph.D., a consultant vitreoretinal surgeon at Moorfields Eye Hospital in London ,who has performed the procedure multiple times for his patients, and paper co-author. “Patients hear about other types of experimental therapy, such as gene therapy, but they’re all just trying to slow vision loss. Artificial vision is the only approach which actually gives patients any vision back. And when you speak to patients with very severe vision loss, that’s what they want.”