- Science Corporation has commercially launched the PRIMA retinal implant in Europe after receiving CE mark approval, enabling availability across 30 European countries
- Clinical trial results published in the New England Journal of Medicine showed significant improvements in functional central vision, including reading ability, in patients with GA due to AMD
- The company is pursuing reimbursement across Europe and continues to work with the FDA to bring PRIMA to the US
Science Corporation announced the European commercial launch of PRIMA, a brain-computer interface (BCI)-based retinal implant system for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company said PRIMA has received a CE mark under the European Union Medical Device Regulation from DEKRA, allowing commercial distribution across 30 European countries.
According to the company, PRIMA is the first and only treatment to demonstrate restoration of functional central vision in patients with GA due to AMD in clinical trials. Results from the multicenter study were recently published in the New England Journal of Medicine, accompanied by an editorial.
Science said PRIMA is the first BCI device to receive CE marking for restoring detailed form vision, including the ability to read letters, numbers, and words. The company has begun country-specific reimbursement applications and clinical site activations across Europe, with the first commercial implantation expected in Germany.
“We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision. For decades, losing central vision to this disease meant losing the ability to read, recognize faces, and ultimately losing independence. There was nonder of Science. “We intend to make access to PRIMA real and reimbursable, as quickly as possible.”
“It has been demonstrated in clinical trials that with PRIMA, we can restore functional central vision in patients blinded by geographic atrophy,” said Frank Holz, MD, lead author of the NEJM publication, principal investigator of the clinical trial, and chair of the Department of Ophthalmology at the University Hospital of Bonn, Germany. “These patients, who had lost their central vision completely, have had it restored and can read letters, numbers, and words.”
The multicenter clinical trial enrolled 38 patients across 17 clinical sites in five countries. According to the published results:
- Patients experienced a mean improvement of 25.5 ETDRS letters, equivalent to more than five lines on the visual acuity chart
- 84% percent of participants reported the ability to read letters, numbers, and words following implantation
- 80% percent achieved improvements of at least 0.2 logMAR (approximately 10 ETDRS letters) at 12 months (P<.001)
- The implant was positioned beneath the atrophic macula without reducing patients’ residual natural vision
PRIMA consists of a subretinal photovoltaic implant used in conjunction with specialized glasses. The glasses project near-infrared light onto the implanted device, which converts the light into electrical stimulation of retinal cells. The system also includes a zoom function that allows patients to magnify text.
Science said the implant features an ultra-thin profile and operates through a wireless design.
In the United States, Science is working with the FDA toward commercialization of PRIMA. The device has received both Breakthrough Device designation and Humanitarian Use Device designation.
