TL;DR
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A study of the PRIMA retinal implant reported continued device-assisted central-vision improvement among patients with advanced geographic atrophy through 36 months. The single-arm trial began with 38 participants, and 27 completed three years; researchers reported surgical complications, while seven deaths were judged unrelated to the implant or procedure.
A study of the PRIMA wireless retinal implant found that patients with advanced geographic atrophy continued to gain device-assisted central vision through 36 months, according to results presented at the American Academy of Ophthalmology annual meeting in New Orleans. The findings offer longer-term evidence for a device designed to help restore central vision, but come from a small, single-arm study and do not establish how it compares with other care.
The PRIMAvera trial enrolled 38 patients at 17 European sites with advanced geographic atrophy, a form of age-related macular degeneration that damages the central retina. At the three-year mark, 27 participants had completed follow-up. Presenter Ehsan Rahimy, MD, of Stanford Medicine, described the study as a phase III-equivalent pivotal single-arm trial, with efficacy and safety as its primary endpoints.
In the implanted eye, visual acuity with the device improved from 0.49 logMAR at 12 months to 0.58 at 36 months, as reported in the study. Rahimy characterized the 36-month result as an average gain of about 30 letters and about five letters better than at 12 months. More than 80% of participants reported being able to read letters, numbers and words at 12 months. Between months 24 and 36, half reported being able to undertake more advanced tasks, including using a smartphone, reading a menu or playing cards.
Researchers also reported that vision in the implanted eye without device assistance remained stable, while the untreated eye lost about 1.4 lines of vision. Across the study period, there were 29 serious adverse events, 24 in the first six months. Reported events included hypotony, retinal tears, macular holes and subretinal hemorrhage. Rahimy said the events did not compromise participants’ natural vision or prevent device-assisted gains; 68% of those who experienced a serious adverse event gained more than 15 letters with the device.
Potential Gains for Central Vision
Geographic atrophy can destroy the central retinal cells needed for activities such as reading and recognizing faces. PRIMA is intended to provide an alternative route for visual signals in areas where photoreceptors have been lost, while leaving peripheral vision to the remaining retina. If the reported results hold up in further study and use, the device could offer some patients functional central vision where current options are limited.
The findings are relevant because the reported improvement persisted over three years, rather than appearing only soon after implantation. Participants’ reports of reading and daily tasks add functional detail to the visual-acuity measurements. However, these are results from a selected group with advanced disease; they do not show that every patient will gain the same abilities or that the device slows the underlying disease.
PRIMA requires surgery and a demanding rehabilitation process. The potential benefit must be weighed against operative risks, follow-up needs and the effort required to learn the system. The study does not yet provide a comparison with a control group, so it cannot establish the implant’s relative benefit against other approaches.
retinal implant for geographic atrophy
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How the PRIMA System Works
PRIMA is a wireless photovoltaic implant placed beneath the retina. The patient wears augmented-reality glasses with a camera that captures a live image. A processor converts that information into pulsed near-infrared light, which passes through the pupil and is absorbed by the implant. The implant converts the light into electrical current to stimulate retinal cells involved in sending visual signals toward the brain.
Patients can adjust settings including brightness and zoom, but the system does not switch on to produce immediate, effortless vision. Rahimy said patients undergo a rigorous postoperative course to train themselves to use it. The updated presentation followed earlier reporting of the trial’s 12-month results. The device was approved in Europe in July, according to the report; Rahimy said its manufacturer, Science Corporation, was on track to seek U.S. Food and Drug Administration approval.
At the meeting, Rahimy said researchers had no information on European sales or possible safety issues arising from use outside the trial. The presentation also reported no implant migration beyond the borders of the atrophy lesion in longitudinal imaging. Postmortem evaluations of two implanted eyes showed no significant fibrosis or chronic inflammation, according to Rahimy.
“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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Questions on Safety and Study Limits
The study had no control group, limiting conclusions about how outcomes compare with those in similar patients who did not receive the implant. Of the original 38 participants, 27 completed 36 months. Seven died during the study; Rahimy said the deaths were not related to the implant or surgery and described them as unsurprising given the group’s age and advanced disease. Four other participants left follow-up after relocating or for other reasons.
Miller said the number of deaths seemed high to her and suggested a comparator would help show what might be expected in a population of similar age. No deaths were considered implant- or procedure-related, according to the report, but the study figures alone do not resolve the broader question she raised. The report did not provide a detailed comparison of mortality with an equivalent group.
The results also do not establish how often complications may occur in broader clinical use, how device outcomes vary among patients, or whether benefits persist beyond three years. Rahimy said he had no data on European sales or possible safety issues since the device’s European approval. The reported postmortem findings involved only two eyes, a limited basis for judging long-term tissue response.
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Regulatory Review and Longer Follow-Up
Science Corporation is preparing to seek FDA approval, according to Rahimy, but the report gave no filing date or expected review timetable. Any U.S. decision will depend on the evidence submitted and the regulator’s review; the meeting presentation itself is not an approval decision.
Further follow-up will be needed to show whether visual gains and reported daily-function improvements continue beyond 36 months, and to clarify the longer-term safety profile. More information on patients who did not complete follow-up, alongside results from any future comparative studies, could help clinicians and patients judge how the benefits and risks apply to people considering the procedure.
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Key Questions
What is PRIMA?
PRIMA is a wireless retinal implant designed to help restore central vision in areas affected by geographic atrophy. It works with camera-equipped augmented-reality glasses and a processor that sends near-infrared light to the implant.
What did the three-year study report?
Among participants followed in the PRIMAvera trial, researchers reported continued device-assisted visual-acuity improvement through 36 months. Twenty-seven of the 38 enrolled patients completed three-year follow-up.
Did the study show that the implant is risk-free?
No. The study recorded 29 serious adverse events, most during the first six months. Rahimy said the events did not compromise natural vision or rule out device-assisted gains, but longer-term safety and outcomes in wider use remain uncertain.
Is PRIMA approved in the United States?
The report said the device was approved in Europe in July. Rahimy said Science Corporation was on track to seek FDA approval, but the report did not give a U.S. filing date or decision timeline.
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