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Add us on GoogleNearly 20 million adults in the U.S. suffer from macular degeneration, an age-related condition which can lead to irreversible blindness and visual impairment. Worldwide, as many as 288 million people are expected to experience its effects by 2040. But a new breakthrough may offer hope.
Regulators in Europe have approved commercial sales of a retinal implant that improves eyesight for patients with age-related macular degeneration. And Science Corp., the startup behind the technology, is already in talks with the Food and Drug Administration (FDA) to bring the device to the U.S. market.
Called Prima, the implant will be available across 30 European countries and could be in the U.S. as early as next year. Germany will be the first country where it is distributed. The company says people who are fitted with it will once again be able to read letters, numbers and words.
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“We have a cochlear implant for vision now,” Science founder and CEO Max Hodak told healthcare news outlet Stat.
Most severe cases
While millions of people are diagnosed with macular degeneration, not all of them lose their vision. In the U.S., at present, however, 1 million people have been declared legally blind due to geographic atrophy, an advanced form of age-related macular degeneration.
Prima is designed for people who suffer from geographic atrophy. The miniscule implant, the size of a grain of rice, works in conjunction with specialized glasses, which project near-infrared light to the implant, which converts it into electrical stimulation signals. The glasses then “zoom in” and magnify the letters, helping patients read.
In a multi-clinical trial, Science tested the implant on 38 patients across five countries. Of that group, 84% reported restored functional central vision, meaning they were once again able to read letters, numbers and words. There was also a mean improvement of 25 letters (more than five lines) on the ETDRS letter chart, the rows of letters often found in optometrists’ offices.
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Investor interest
The regulatory approval and the successful trial have made Science something of a darling among investors. The company has raised almost $500 million since it was founded in 2021, and most recently closed a $230-million round in March.
Rather than building a device that’s expected to work in years, like the company touting a bionic eye two decades ago that ultimately folded, Science’s product is offering a solution that can be used today.
“For decades, losing central vision to this disease meant losing the ability to read, recognize faces, and ultimately losing independence,” the company said in a statement.
“There was no viable treatment. Now there is. We intend to make access to PRIMA real and reimbursable, as quickly as possible.”
The company says it expects to sell between 20 and 40 devices by the end of the year. If U.S. approval is granted, it says, it expects sales to reach 200 by the end of next year.
Because most people suffering from geographic atrophy are over 65, the device could be covered by Medicare. However, those details still need to be finalized after FDA approval.
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Chris Morris is a veteran journalist with more than 35 years of experience at many of the internet's biggest news outlets. In addition to his activities as a writer, reporter and editor, Chris is also a frequent panel moderator and speaker at major conferences, including CES and South by Southwest.
