The European Union has approved the commercial use of an implant designed to partially restore central vision lost due to geographic atrophy, a severe and common form of age-related macular degeneration. This marks the world’s first device of its kind to receive sales approval, with availability in Germany and Great Britain expected by the end of the year.
The implant, named PRIMA, was developed by the American company Science Corporation, based in Alameda, California. The device, which is the size of a pinhead, is implanted under the retina and works in conjunction with glasses that have a built-in camera.
How the PRIMA Implant Works
Geographic atrophy is a progressive and typically irreversible form of dry age-related macular degeneration (AMD). This condition gradually destroys the macula, the area of the retina responsible for central vision and reading ability.
The implant’s chips convert light into electrical impulses that stimulate the bipolar cells of the retina, which usually remain undamaged in this disease. These cells, which typically receive signals from damaged photoreceptors, create an image that the brain can interpret.
The glasses also generate energy from light, similar to a solar panel, eliminating the need for an external power source. In a recent study involving a small group of patients, the implant helped restore central vision and improved visual acuity in 80% of patients.
“Patients using PRIMA achieved approximately 20/160 vision, meaning they went from a state of blindness to being able to see,” said Frank Brody, an ophthalmologist at Science Corporation.
Most side effects were related to the surgical procedure and resolved within two months. According to Brody, some patients began to notice improvements as early as one day after surgery. After the procedure, the medical team trains patients to use the specialized glasses.
Next Steps: Approval in the USA
The device received CE certification under the European Union Medical Devices Regulation, allowing its use in EU countries and Great Britain.
In the United States, the U.S. Food and Drug Administration (FDA) has designated the device as a “breakthrough medical device” and a “humanitarian use device.” According to Darius Shahidi, director of Science Corporation, this is a significant step toward future approval in the U.S.
“We have already selected centers in Germany, trained surgeons there, and plan to start the first surgical procedures shortly,” said Shahidi.
Sunir Garg from Wills Eye Hospital in Philadelphia believes that further studies involving a larger number of patients, as well as long-term safety data, are necessary before the device can be widely used. He noted that researchers also need to determine which specific patient groups may benefit most from the implant.
Science Corporation is also exploring the potential of the implant to treat other eye diseases, including Stargardt disease, which primarily affects the macula.
Source: Clarín
