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In a European study of 38 people with advanced geographic atrophy, vision measured with the PRIMA retinal implant continued to improve through 36 months; 27 participants completed that follow-up. The single-arm study reported surgical and device-related adverse events, mostly in the first six months, and seven deaths judged unrelated to the implant or procedure. Longer-term results and comparisons with other care remain important questions.
People with advanced geographic atrophy who used the PRIMA retinal implant had continued improvement in device-assisted central vision through three years, according to results presented at the American Academy of Ophthalmology annual meeting. In the European PRIMAvera study, 27 of 38 participants completed 36 months of follow-up; the findings come from a single-arm trial, not a comparison with an untreated control group.
At 36 months, average visual acuity with the device was reported as -0.59 logMAR, equivalent in the presentation to a gain of about 30 letters. The report described this as roughly five letters better than the 12-month result. Separately, vision in the implant-treated eye without device assistance remained stable, while the untreated eye lost about 1.4 lines, according to the study presentation. These measures address different aspects of vision and should not be read as a direct comparison of treatment effects between groups.
More than 80% of patients said they could read letters, numbers and words at 12 months. Between months 24 and 36, half reported being able to do more demanding tasks, including using a smartphone, reading a menu or playing cards. Such reports describe participants’ experience; the study summary does not provide a separate controlled assessment of those activities.
Across three years, researchers recorded 29 serious adverse events, 24 of them in the first six months. Reported events included six cases of hypotony, five subretinal hemorrhages, four minor retinal tears and three macular holes. Presenter Ehsan Rahimy of Stanford Medicine said the events did not compromise participants’ natural vision or prevent device-assisted gains. He reported that 68% of participants who experienced a serious adverse event gained more than 15 letters with the implant.
A New Route to Central Vision
Geographic atrophy is an advanced form of age-related macular degeneration that damages the central retina. The PRIMA system is designed to provide a form of central visual input where retinal cells responsible for detecting light have been lost, while leaving peripheral vision available. A sustained gain over three years could matter to people whose central vision loss affects reading and everyday tasks, though this study does not establish how the device compares with other options or how broadly its results will apply.
The results also offer longer follow-up than the 12-month findings presented at the previous AAO meeting. That added observation is useful for evaluating whether early gains persist and how complications unfold over time. The study’s small cohort and lack of a control arm, however, limit conclusions about the size of benefit attributable to the implant and its risks relative to alternative care.
retinal implant for geographic atrophy
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How the PRIMA Study Worked
The PRIMAvera trial enrolled 38 people at 17 sites in Europe with advanced geographic atrophy. Rahimy described it as a phase III-equivalent pivotal, single-arm study, with efficacy and safety as its primary endpoints. The efficacy endpoint was a clinically meaningful visual-acuity improvement, defined as at least 0.2 logMAR. The supplied results report the 36-month average but do not specify here how many participants met that endpoint.
PRIMA is a wireless photovoltaic implant placed beneath the retina. The patient wears augmented-reality glasses with a camera; a processor converts the camera feed into pulsed near-infrared light, which reaches the implant and is converted into electrical signals intended to stimulate retinal cells. Users can adjust settings including brightness and zoom. This requires postoperative training, Rahimy said, rather than providing vision immediately after surgery.
The device received approval in Europe in July, according to the meeting report. Rahimy said its manufacturer, Science Corporation, was on track to seek U.S. Food and Drug Administration approval. He said he did not have data on European sales or possible safety issues following market introduction.
“The PRIMA system produced durable, clinically meaningful restoration in central vision in patients with geographic atrophy, extending through 36 months.”
— Ehsan Rahimy, MD, Stanford Medicine
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Limits in Follow-Up and Safety
Eleven of the 38 enrolled participants did not complete 36-month follow-up. Seven died during the study, and Rahimy said the deaths were not related to the implant or surgery; four other participants left follow-up after relocating or for other reasons. Miller said a comparator population would help put the number of deaths in perspective. Rahimy replied that participants had bilateral end-stage disease and a mean age of about 79.
The trial was not designed with a control group, and the available report does not establish how the device performs in a broader population, how long gains persist beyond three years, or how frequently complications occur in routine use. The presentation also did not provide European sales figures or post-approval safety data. These results show what happened among participants followed in this study; they do not settle those wider questions.
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Regulatory Review and Longer Follow-Up
Science Corporation is expected to pursue FDA review, according to Rahimy’s comments at the meeting; the supplied report gives no filing date or decision timeline. Any U.S. authorization would require regulatory review of the evidence and device safety. Researchers and clinicians will also need further follow-up to understand durability, complications and patient experience outside the trial setting.
For now, the 36-month results extend the evidence reported at 12 months but do not establish long-term outcomes beyond that period. Additional data, including the status of participants who did not complete follow-up and any post-market safety findings in Europe, could clarify how the system performs over time.
central vision aid for macular degeneration
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Key Questions
What is the PRIMA retinal implant?
PRIMA is a wireless photovoltaic implant placed beneath the retina. It works with camera-equipped glasses and a processor that sends near-infrared light to the implant, which generates electrical signals intended to stimulate retinal cells.
How many people completed the three-year follow-up?
Twenty-seven of the 38 people enrolled in the European PRIMAvera study completed 36 months of follow-up. Seven participants died, with the deaths reported as unrelated to the implant or procedure; four others could not continue follow-up for other reasons.
Did the study report vision gains?
Researchers reported average device-assisted visual acuity of -0.59 logMAR at 36 months, described as about a 30-letter gain and roughly five letters better than at 12 months. The study was single-arm, so it did not compare outcomes against a control group.
What safety events were reported?
The study recorded 29 serious adverse events over three years, 24 during the first six months. Reported events included hypotony, subretinal hemorrhage, minor retinal tears and macular holes. The presentation said these events did not compromise natural vision, but longer-term and post-market safety questions remain.
Is PRIMA approved in the United States?
The meeting report said the device was approved in Europe in July. Rahimy said the manufacturer was on track to seek FDA approval, but no U.S. filing date or decision was provided.
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