PRIMA Receives European CE Marking: First Vision-Restoring Neural Interface Enters the Commercial Market
Science Corporation announced that the PRIMA system has received CE marking for sale in Europe
On 22 July, Science Corporation announced that DEKRA had granted CE marking to PRIMA. The company is preparing to sell the system in 30 European countries, applying for reimbursement, and bringing clinics on board. The first commercial implant is expected to be placed in Germany.
Geographic atrophy caused by age-related macular degeneration destroys the central retina, the area people use to read, recognize faces, and see fine details. Photoreceptors in this area die, while some patients retain the inner retinal neurons. PRIMA delivers images to these surviving cells and uses them as an entry point into the visual pathway.
A surgeon places a square implant measuring 2 × 2 millimeters beneath the retina. The glasses convert the image into near-infrared light, and the implant's photovoltaic cells convert that light into electrical pulses that stimulate retinal neurons. The brain receives a central prosthetic image. The user adjusts the magnification in the glasses to make out letters and details.
For retinitis pigmentosa, MCO-010 gene therapy makes the remaining bipolar cells responsive to light. PRIMA takes a different approach: electronics deliver an external signal to the surviving retinal cells.
The clinical results were reported in the PRIMAvera study published in the New England Journal of Medicine. In this open-label study without a group receiving a different treatment, 38 people with severe geographic atrophy received the implant, and 32 completed the one-year assessment. Of these participants, 26 improved their prosthetic visual acuity by at least 0,2 logMAR, which corresponds to about ten letters on a standard eye chart. The trial registry states that each participant's outcome was compared with their own baseline vision.
In March, Science reported that PRIMA had been submitted for CE marking. The company now says that the marking has been granted. Access to the system will expand as clinics begin performing the surgery, teaching patients to use the glasses, and securing reimbursement. PRIMA provides a new input into the visual system after age-related damage has already destroyed the light-sensing receptors.