Science Corporation has become the first company to receive European approval for an implant that partially restores vision in people with age-related blindness. The CE mark allows the device to be marketed in the EU and UK.
Called PRIMA, the implant is intended for patients with geographic atrophy, the advanced stage of dry age-related macular degeneration (AMD). This irreversible condition affects about 8 million people worldwide, with current treatments only slowing progression rather than restoring vision.
How the Retinal Implant Works
The pinhead-sized implant is placed under the retina and works with smart glasses that capture images and transmit them via invisible infrared light without affecting remaining vision.
The implant converts infrared signals into electrical impulses that activate surviving retinal cells, bypassing damaged photoreceptors unable to detect light.
The smart glasses are powered by energy harvested from incoming light, functioning similarly to solar panels. This self-powered design removes the need for an external power supply while enabling the implant to operate.
A small October clinical study found improved central vision in nearly 80% of participants, with average acuity improving from 20/200 to about 20/160.
Researchers noted that most adverse effects were linked to the implantation surgery rather than the device itself, with the majority resolving within two months after the procedure.
Despite the encouraging results, independent specialists advise against drawing firm conclusions too soon. Sunir Garg of Wills Eye Hospital called the technology “impressive” but said larger clinical trials and long-term safety data are needed before widespread use. He also noted it remains unclear whether the treatment benefits all patients or only certain groups.
Regulatory Approval Limited to Europe
Science Corporation has received CE marking, allowing the PRIMA implant to be marketed in the EU and UK. In the U.S., it has FDA “Breakthrough Device” and “Humanitarian Use Device” designations, which expedite review but do not authorize commercial sale.
According to Science Corporation executive Darius Shahida, the company has already identified treatment centers and trained ophthalmic surgeons in Germany. The first commercial implantations are expected to begin in Germany and the United Kingdom later this year.
Science Corporation is also testing the PRIMA implant for other retinal disorders, including Stargardt disease, which affects the macula. No plans involving Brazil have been announced so far.
Read the original article on: exame
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