PRIMA, a subretinal photovoltaic implant designed to restore central vision in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has launched commercially in Europe after receiving CE marking under the European Union Medical Device Regulation. The authorization allows commercialization in 30 European countries, with the first commercial implantation expected in Germany.

The launch follows publication of the multicenter PRIMA clinical trial in The New England Journal of Medicine, which evaluated the device in 38 patients treated at 17 centers across 5 countries. Investigators reported a mean gain of 25.5 ETDRS letters. At 12 months, 80% of patients achieved prosthetic visual acuity improvements of at least 10 ETDRS letters (logMAR 0.2; P<.001), and 84% were able to read letters, numbers, and words using the system. Implantation beneath the atrophic macula did not reduce mean residual natural vision.

The PRIMA system combines an ultrathin wireless subretinal implant with external glasses that project near-infrared light onto the implant, which converts the light into electrical stimulation of the retina. The glasses also include a magnification feature to enlarge text.

In the United States, the device has received FDA Breakthrough Device and Humanitarian Use Device designations. The company said it is working with the FDA toward potential US commercialization. RP