Science Corporation published preliminary data from a late stage, multi-center clinical trial of a retinal implant that showed promising results Tuesday.
Using this prosthetic, scientists partially restored vision to people whose central visual field has holes or blurry spots. Trial participants could read text and recognize playing cards when using the implant, even though they were legally blind.
Ophthalmologist Frank Holz, the trial’s scientific coordinator, called the results a “milestone” in treating severe vision loss caused by age-related macular degeneration. “Prior to this, there have been no real treatment options to improve vision for these patients,” said Holz, a professor at University of Bonn, Germany.
If this technology continues to succeed, both in Europe and in the United States, it could be welcome news. Twenty million people have age-related macular degeneration in the U.S., and it is the most common cause of severe eyesight loss among people 50 and older. The county’s aging population will likely exacerbate this problem. It’s partly why Science acquired Paris-based Pixium Vision, which originally developed this implant, in 2023.
“I’m excited about this [research],” said James Weiland, a University of Michigan biomedical engineering and ophthalmology and visual sciences professor who was not involved with the study. “We’ve been kind of waiting for this in the field, and we’re looking forward to more details in a peer-reviewed format.”
The setup includes an implant, a camera mounted on glasses and a pocket computer. The glasses gather infrared light from the world and beam it onto the subretinal implant. The implant — replete with 400 whisper-thin panels — then stimulates the retina with electrical impulses that are sent to the brain. The implant effectively mimics the typical process of vision formation.
“In some sense, I think of this as tricking the eye into seeing infrared,” said Science Corporation CEO Max Hodak in an interview with STAT.
Science enrolled 38 patients in the trial, though six people dropped out before testing. All of the patients had some light sensitivity — total absence of light perception is rare for people who are blind. Researchers determined the participants’ improvement in visual acuity through the classic eye chart, a staple in stuffy doctors’ offices the world over.
After twelve months of use, the participants could read, on average, nearly five more lines, or 23 letters down the chart. It’s equivalent to a person’s eyesight improving from 20/320 to 20/200, which is the threshold for blindness in the United States.
Joseph Rizzo was “impressed” by the study’s results and the eyesight improvements, but the Harvard Medical School ophthalmology professor cautioned against using the layperson’s understanding of visual acuity. The participants stood closer to the eye chart than is typical and the camera allows the user to magnify the image.
A Science spokesperson said the study coordinators accounted for the different physical distance to the chart and that using the zoom function wouldn’t affect the letter or number’s resolution. However, they did not have data on how often a participant used the zoom.
Even with these caveats, Rizzo still praised the technology. “The scientific backbone for this device, I’ve followed it for almost 20 years,” he said. “I think the technology is exceptionally good. It is a really noteworthy device.”
This research stems from Daniel Palanker, a Stanford University ophthalmologist who many consider one of the pioneers for optical technology, particularly laser-based cataract surgery and optical prosthetics. He is helping Science develop the next generation of the implant, which sees this current implant as a proof of concept for the technology in humans after successful animal trials.
The California-based company plans to release a more comprehensive analysis of this trial’s data before the end of the year. Company executives hope to leverage the trial’s success and are filing for regulatory approval in Europe. They are also expanding a feasibility trial of the implant in the United States, in addition to pursuing other brain-computer interface technologies.
“This device is relatively early, but even at this stage, the impact that it’s had for these patients is enormous, and there’s really clear ways to make it better,” said Hodak, who served as Neuralink’s president during the company’s founding. “It feels like this is on a path of something that within a decade is gonna be, I hope, pretty ubiquitous.”
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