At the American Academy of Ophthalmology meeting, researchers reported that the PRIMA wireless retinal implant produced durable, clinically meaningful gains in central vision for people with geographic atrophy, the advanced dry form of age-related macular degeneration. In the PRIMAvera trial, 38 patients with end-stage GA were implanted; 27 completed 36 months of follow-up. Average visual acuity improved by about 30 letters at 36 months, and more than 80% could read letters, numbers, and words at 12 months. Between 24 and 36 months, half reported doing tasks like using a smartphone, reading a menu, or playing cards.
PRIMA is a subretinal photovoltaic implant paired with augmented-reality glasses. A camera in the glasses captures a live feed, a processor converts it into pulsed near-infrared light, and the implant turns that light into electrical current that stimulates retinal cells, bypassing lost photoreceptors. The untreated fellow eye lost about 1.4 lines of vision over the study, while the implanted eye's natural vision remained stable.
Safety was generally manageable, but not trivial. Twenty-nine serious adverse events occurred over three years, 24 in the first six months; common events included hypotony, subretinal hemorrhage, retinal tear, and macular hole. Patients who had an SAE still often gained vision, and their natural vision was not compromised. However, seven patients died during the study, none judged related to the implant or surgery. Discussant Joan Miller said the number seemed high for a group with mean age 78.9 and called for a comparator to interpret it.
Rahimy noted that all patients had bilateral end-stage GA and were older than typical candidates for GA treatment. The device is approved in Europe, and the manufacturer plans to seek FDA approval. Rahimy said he had no data on European sales or post-approval safety issues.