Science Corporation on Tuesday published preliminary data from a late-stage, multicenter clinical trial of a retinal implant that showed promising results.
Using this prosthesis, scientists have partially restored vision to people whose central visual field has holes or blurred spots. Test participants were able to do that reading text and recognizing playing cards when using the implant, even though they were legally blind.
Ophthalmologist Frank Holz, the scientific coordinator of the study, called the results a “milestone” in the treatment of severe vision loss caused by age-related macular degeneration. “Before there were no real treatment options to improve the vision of these patients,” says Holz, professor at the University of Bonn, Germany.
If this technology continues to succeed, both in Europe and the United States, it could be welcome news. Twenty million people have age-related macular degeneration in the US, and that is the case most common cause of severe vision loss in people aged 50 and over. That of the province aging population will likely make this problem worse. It’s partly why Science acquired Paris-based Pixium Vision, which originally developed this implant, in 2023.
“I’m excited about this [research]” says James Weiland, professor of biomedical engineering and ophthalmology and visual sciences at the University of Michigan, who was not involved in the study. “We’ve been waiting a bit for this in the field and we look forward to more details in a peer-reviewed format.”
The setup includes an implant, a glasses-mounted camera and a pocket computer. The glasses collect infrared light from the world and beam it to the subretinal implant. The implant – packed 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 facial shaping.
“In a way, I think of this as tricking the eye into seeing infrared,” said Max Hodak, CEO of Science Corporation, in an interview with STAT.
Science enrolled 38 patients in the trial, although six people dropped out before testing. All patients had some photosensitivity; a total absence of light perception is rare in blind people. Researchers measured the improvement in participants’ visual acuity using the classic eye chart, a staple in cramped doctors’ offices around the world.
After twelve months of use, participants were able to read an average of almost five more lines, or 23 letters further down the graph. It is equivalent to improving a person’s eyesight from 20/320 to 20/200, which is the threshold for blindness in the United States.
Joseph Rizzo was “impressed” by the study results and the improvements in vision, but the Harvard Medical School ophthalmology professor cautioned against using the layman’s understanding of visual acuity. The participants stood closer to the eye chart than normal and the camera allowed the user to enlarge the image.
A spokesperson for Science said the study coordinators took into account the different physical distances from the map and that using the zoom function would not affect the resolution of the letter or number. However, they had no data on how often a participant used Zoom.
Despite these caveats, Rizzo still praised the technology. “The scientific backbone of this device, I’ve been following it for almost 20 years,” he said. “I think the technology is exceptionally good. It is truly a remarkable device.”
This research stems from work by Daniel Palanker, a Stanford University ophthalmologist who is considered by many to be one of the pioneers in the field of optical technology, particularly laser-based cataract surgery and optical prosthetics. He helps science develop the next generation of the implant. The company sees the current implant as a proof of concept for the technology that will come next in humans successful animal experiments.
The California-based company plans to release a more comprehensive analysis of the data from this study before the end of the year. Company executives hope to capitalize on the trial’s success and are filing for regulatory approval in Europe. They are also expanding feasibility test 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 it has had on these patients is enormous, and there are very clear ways to improve it,” Hodak said., who served as president of Neuralink during the company’s founding. “It feels like this is on the path of something that within 10 years, I hope, will be quite ubiquitous.”
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