PRIMA is a subretinal photovoltaic implant (2x2mm, 30 micrometers thick) containing 378 independently controlled pixels, each 100 microns wide. The system bypasses lost photoreceptors by stimulating bipolar cells directly. Augmented reality glasses with an embedded camera capture images and project them as near-infrared light (880nm) onto the implant, providing both power and data — no cables or batteries required. In the PRIMAvera trial of 38 patients with geographic atrophy due to AMD, 80% achieved significant visual acuity improvement, with a mean 23-letter (4.6 lines) gain at 12 months. Results published in the New England Journal of Medicine (Oct 2025). Next-gen versions may feature 10,000 pixels per chip.
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗