Prima is a tiny, photovoltaic sub-retinal implant that can restore vision to those with geographic atrophy.
US neural engineering company Science Corporation has received EU approval for its medtech vision correction implant.
‘Prima’ is claimed by the company as the “first and only treatment” in the world shown to restore central vision in patients with geographic atrophy caused by age-related macular degeneration – the leading cause of irreversible blindness affecting more than 5m people worldwide.
With close regulatory approval, small photovoltaic sub-retinal implants can be sold in 30 European countries.
The implant is paired with special glasses that emit near-infrared light into the implant, which converts the light into electrical signals for stimulation. The ‘zoom-in’ feature allows users to zoom in on characters.
Science Corporation has also received the US Food and Drug Administration’s ‘Breakthrough Device’ and ‘Human Use Device’ designations for Prima, and is working to bring the device to consumers in the country.
A paper published in the New England Journal of Medicine last year showed that Prima was able to restore vision in the majority of its participants.
In a sample of 38 patients across 17 clinical sites in five countries that participated in the study, 84pc reported the ability to read letters, numbers and words again, recovering the central visual function. 80pc of patients tested were reported to have achieved a significant improvement in visual acuity.
“We are proud to be the first BCI [brain-computer interface] a company with CE [Conformité Européenne] a marked tool for restoring the vision of detailed form,” said Science founder and CEO Max Hodak.
“For decades, the loss of vision essential to the disease meant the loss of the ability to read, see faces, and ultimately the loss of independence. There was no effective treatment.
“We aim to make access to Prima a reality and restore, as quickly as possible.”
The company has announced country-specific reimbursement requests and the activation of Prima’s clinical site across Europe. The first commercial transplant is expected in Germany soon.
“The CE marking is an exciting moment, making Prima commercially available to patients,” said Prof. Frank Holz, MD, lead author of the paper and chairman of the Department of Ophthalmology at the University of Bonn Hospital in Germany.
“It has been shown in clinical trials that with Prima, we can restore functional vision to patients blinded by geographic atrophy. These patients, who had lost their central vision completely, have been restored and can read letters, numbers and words.”
Science Corporation has raised nearly $490m in total funding since its founding in 2021, with the majority of the funding being contributed to the Prima transaction. The company is based in California and has offices in Paris.
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