Overview
- - The PRIMAvera trial enrolled 38 people with geographic atrophy at 17 centers across five European countries, with 32 completing 12 months of follow-up.
- - Using the prosthesis, 27 of 32 participants (84%) regained the ability to read letters, numbers or words, with average gains of about 25 letters (roughly five lines) and individual improvements up to 59 letters.
- - The system pairs a 2×2 millimeter wireless photovoltaic chip implanted under the central retina with augmented-reality glasses that project infrared images onto the implant, allowing use alongside patients’ natural peripheral vision.
- - Procedure-related adverse events were reported in 19 of 32 participants—including ocular hypertension, peripheral retinal tears and subretinal bleeding—but they resolved within weeks to two months, according to investigators.
- - The company has reportedly sought regulatory clearance in the EU and U.S.; the device currently provides high-contrast black-and-white vision, and teams are developing grayscale and higher-resolution upgrades.