Science Corp. today announced clinical trial data demonstrating the efficacy of its Prima brain-computer interface (BCI) retinal implant.
Findings published in The New England Journal of Medicine (NEJM) outlined the restoration of functional central vision to patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD) with Prima. It marks the latest milestone from the company led by founder Max Hodak, who also co-founded BCI company Neuralink.
Alameda, California-based Science owns the Prima retinal implant technology developed by Pixium Vision. The Prima System, a photovoltaic substitute of photoreceptors, already has FDA breakthrough device designation. It provides simultaneous use of the central prosthetic and peripheral natural vision.
Prima restores vision by directly activating the retina if rods and cones have been lost. It features a small light-powered implant placed under the retina and a special pair of glasses. The glasses have an embedded camera and infrared projector that sends light signals to the implant to provide power and data.
Science submitted Prima for commercial availability in the U.S. and Europe in June. As it looks to bring the system to market, it launched a patient registry last month.
“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 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.”
More about Prima and the data shared by Science Corp.
Prima, a wireless implant system, acts like a miniature solar panel. With a zoom-in feature, patients can magnify letters. It has an ultra-thin profile and seamless, wireless integration to help those with central vision loss.
The device combats the loss of photoreceptors in the retina through an array of artificial photoreceptors. This stimulates the remaining cells to carry visual signals to the brain. Unlike conventional therapies that attempt to slow disease progression, Science says Prima directly restores lost vision.
Science’s trial evaluated Prima in 38 patients across 17 sites in five countries. Key findings incldued a mean improvement of 25.5 letters (more than five lines) on the ETDRS letter chart. Additionally, 84% of patients reported the ability to read letters, numbers and words.
Investigators reported that 80% of patients achieved significant prosthetic visual acuity improvements at 12 months. They also saw no significant decline in mean existing peripheral natural vision.
According to Science, the implant can take place safely under the atrophic macula. Serious adverse events occurred primarily within the first two months post-implant, the company said, though it didn’t disclose the amount of serious adverse events. However, the company reports that it resolved 95% of those events within two months.
Science said the Data Safety Monitoring Board for the study recommended PRIMA for European market approval. It found that the benefits outweighed the risk of the implantation surgery. The company submitted for regulatory approval in Europe and hopes to bring Prima to patients next year. It also has its FDA approval process “underway.”
“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.”
