PRIMA receives CE mark; Science announces European commercial launch

Science Corporation/PRIMA retinal implant

Science Corporation's PRIMA retinal implant received a CE mark under the EU Medical Device Regulation from notified body DEKRA, allowing sale in 30 European countries, and Science began its European commercial launch. PRIMA restores some central vision to people blinded by geographic atrophy, the late dry form of age-related macular degeneration. Science calls it the first brain-computer interface to be CE-marked for restoring form vision.

• How it works: glasses project near-infrared light onto a 2×2 mm solar-cell chip under the retina, which turns it into electrical pulses for the remaining retinal cells; glasses can zoom to enlarge text.
• PRIMAvera trial (38 patients, 17 sites): mean gain of 25.5 letters on an eye chart at 12 months; 80% improved by 10 or more letters; natural vision was not reduced.
• The first commercial implant is expected in Germany; reimbursement applications and clinic activations are under way. Price was not disclosed.
• In the US, FDA review is ongoing; PRIMA holds Breakthrough Device and Humanitarian Use designations.