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At an American Academy of Ophthalmology meeting, researchers reported that the PRIMA retinal implant was associated with continued device-assisted central vision gains through 36 months in a study of people with advanced geographic atrophy. The results come from a small, single-arm study: 27 of 38 participants completed follow-up, and the findings do not establish how the device compares with other care.
People with advanced geographic atrophy who received the PRIMA retinal implant continued to show improved device-assisted central vision through 36 months, according to updated results presented at the American Academy of Ophthalmology annual meeting. The study included 38 patients in Europe, 27 of whom completed three years of follow-up; the findings are encouraging but come from a single-arm trial without a comparison group.
At 36 months, average visual acuity using the PRIMA system was reported as 0.58 logMAR, compared with 0.49 logMAR at 12 months. The presentation described the three-year result as an average gain of about 30 letters, roughly five letters better than the 12-month result. The study defined clinically meaningful improvement as a gain of at least 0.2 logMAR. These measures refer to vision with assistance from the device, not an equivalent restoration of unaided natural vision.
Patients also reported functional abilities. More than 80% reported being able to read letters, numbers and words at 12 months. Between 24 and 36 months, half reported being able to do more advanced activities, including using a smartphone, reading a menu or playing cards. The report did not provide a control group against which to compare these outcomes.
Without device assistance, vision in the implanted eye remained stable on average, while the untreated eye lost about 1.4 lines of vision, according to the presentation. Researchers reported 29 serious adverse events over three years; 24 occurred during the first six months. Events included hypotony, retinal tears, subretinal hemorrhage and macular holes. The presenter said these events did not compromise patients’ natural vision or prevent device-related gains, though the study figures do not remove the need to weigh individual surgical risks.
What Three-Year Vision Gains Could Mean
Geographic atrophy is an advanced form of age-related macular degeneration that damages the retina’s central region and can impair tasks such as reading and recognizing faces. A device that enables sustained central vision for some patients could offer a different approach to managing the effects of advanced disease. The reported gains matter because they continued beyond the study’s earlier 12-month results and included patient-reported everyday tasks.
However, the findings are not proof that the implant will produce the same results broadly or outperform other options. The trial was small and had no comparison group, so changes cannot be separated as confidently from differences in participants, follow-up or assessment. The results also describe vision with the system; patients need training to use it, and it does not restore normal sight. For patients and clinicians, the data are a reason to follow the technology’s evaluation, not a basis for assuming a particular outcome.
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How the PRIMA System Works
PRIMA is a wireless photovoltaic implant placed beneath the retina. It is designed to replace some functions of lost photoreceptors in areas affected by atrophy while preserving natural peripheral vision. Patients use augmented-reality glasses with a camera. A processor converts the camera’s image into pulsed near-infrared light, which passes through the pupil and is absorbed by the implant. The implant then generates electrical signals that stimulate retinal cells involved in sending visual information to the brain.
The PRIMAvera study enrolled 38 people at 17 sites in Europe with advanced geographic atrophy. Presenter Ehsan Rahimy of Stanford Medicine characterized it as a pivotal, phase III-equivalent single-arm study, with efficacy and safety as its main endpoints. The new results build on 12-month findings presented at the same annual meeting the previous year. The report said the device received approval in Europe in July; Rahimy said the manufacturer, Science Corporation, was on track to seek U.S. Food and Drug Administration approval.
“The PRIMA system produced durable, clinically meaningful restoration in central vision in patients with geographic atrophy, extending through 36 months.”
— Ehsan Rahimy, MD, of Stanford Medicine, presenting the study
Limits, Safety and Follow-Up
The study does not establish how PRIMA compares with no implant or other treatment because it had no control group. Of the original 38 participants, 27 completed 36 months. Seven died during the study; investigators said the deaths were unrelated to the implant or procedure. Four other participants left follow-up after relocating or for other reasons. The available report does not provide enough detail to determine how attrition affected the results.
Miller questioned whether the number of deaths warranted comparison with what might be expected in a similar population. Rahimy replied that participants had bilateral, end-stage disease and a mean age of 78.9, and said the deaths were not unexpected in that group. No deaths were considered related to the device or surgery, according to the report. That does not settle how the safety profile will look in a larger or different patient population.
Serious adverse events were concentrated early: 24 of 29 occurred in the first six months. The presenter reported no implant migration beyond the geographic atrophy lesion borders in longitudinal imaging, and no significant fibrosis or chronic inflammation in postmortem assessments of two implanted eyes. These observations are limited in scale. Rahimy said he had no data on European sales or possible safety issues after approval, so real-world use and longer-term safety remain unclear.
FDA Review and Further Evidence
Science Corporation is expected to pursue FDA approval, according to Rahimy, but the report did not give a filing date or describe the agency’s review timetable. Any U.S. authorization would depend on the evidence submitted and the FDA’s assessment; approval in Europe does not determine that outcome.
Further follow-up and data from broader use could help clarify how durable the vision gains are, how often complications occur, and which patients are most likely to benefit. A controlled comparison would also help place the visual-acuity and daily-task reports against outcomes without the implant. Until more information is available, the three-year results should be understood as evidence from a small study, not a settled estimate of benefits and risks for every person with geographic atrophy.
Key Questions
What did the PRIMA study report?
Researchers reported that device-assisted central visual acuity improved through 36 months among people with advanced geographic atrophy who received the implant. The study began with 38 participants, and 27 completed three-year follow-up.
Does the implant restore normal vision?
The results do not show restoration of normal sight. PRIMA is designed to provide device-assisted central vision using an implant and augmented-reality glasses, and patients need training to use the system.
What risks were reported?
The study recorded 29 serious adverse events over three years, 24 in the first six months. Reported events included hypotony, retinal tears, subretinal hemorrhage and macular holes. Study findings cannot predict an individual patient’s risk.
Is PRIMA approved in the United States?
The report said the device was approved in Europe in July. Rahimy said the manufacturer was on track to seek FDA approval, but the presentation did not provide a U.S. filing date or decision timetable.
How strong is the evidence so far?
The results extend follow-up to three years, but they come from a small, single-arm study with no comparison group. Larger and comparative evidence would help clarify how benefits and risks apply across patients.
Source: rss
