Prima 378-Pixel Photovoltaic Implant Gains EU Approval July 2026 for Advanced AMD

The Prima implant replaces lost photoreceptors with photovoltaic pixels that convert 880 nm near-infrared light into current delivered directly to intact bipolar and ganglion cells. A 5-megapixel camera at 30 frames per second feeds a pocket processor that modulates the laser projector on the glasses; each pixel contains two photodiodes for simultaneous signal generation and power harvesting, eliminating batteries. Clinical data from the European pivotal trial showed 81 percent of recipients achieving functional central vision after six months of training.

Pixium Vision's earlier IRIS II and PRIMA trials established that residual inner-retinal circuitry remains functional in dry AMD, a finding replicated in the 2026 cohort. The device operates at safe irradiance levels below 1 mW per mm squared, avoiding thermal damage documented in earlier epiretinal arrays. Operationally this means patients regain high-contrast near tasks without external power leads, shifting AMD management from purely pharmacological to hybrid prosthetic care.

FDA clearance remains pending with a decision expected after review of the same 80 percent endpoint data package submitted to the EMA. Next milestones include a 2027 US pivotal expansion and integration of higher-density 600-pixel arrays already prototyped in primate models. Real-world deployment will require specialized low-vision rehabilitation programs to map the new prosthetic field onto existing cortical maps.