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Yes. Three-year results from the European PRIMAvera trial indicate that vision gains from the PRIMA retinal implant can persist for at least 36 months in adults with geographic atrophy (GA) caused by dry age-related macular degeneration. The finding is encouraging but is not yet a randomized proof of effectiveness: there was no control group, and fewer than half of the original participants provided three-year efficacy data.
What the 36-month PRIMAvera results show
PRIMAvera enrolled 38 patients at 17 European centers. At the 36-month assessment, 18 patients were evaluable for efficacy and 27 for safety. Among the efficacy group, mean visual acuity improved from approximately 20/460 before implantation to approximately 20/120 with the device. Fourteen of 18 patients (78%) improved by at least two chart lines, and the same 14 patients (78%) improved by at least three lines.
The results were presented at the 2026 American Academy of Ophthalmology meeting. Lead author Joseph Martel, MD, said the team was “very gratified” that the gains observed at 12 months persisted through 36 months.
Why the numbers need context
The percentages apply to the 18 patients who had three-year efficacy assessments, not to all 38 people originally enrolled. The report did not include a concurrent control group, so it cannot separate the implant’s effect from every other factor that might influence measured vision. The three-year finding is therefore a durability signal from an early clinical study rather than a definitive comparative trial result.
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When the implant was switched off, residual vision in the implanted eyes stayed essentially unchanged over the three-year period. Untreated fellow eyes continued to decline. That pattern is consistent with a device-specific contribution, but the absence of randomization and the incomplete follow-up still limit the strength of the conclusion.
How PRIMA creates an image
A subretinal photovoltaic chip
PRIMA uses a subretinal photovoltaic implant with 378 light-powered pixels. The chip is placed beneath the retina, where it is intended to stimulate surviving retinal neurons rather than replace the entire visual pathway.
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Camera glasses and near-infrared projection
Proprietary glasses provide the external power and image signal. A forward-facing camera captures the scene, while an eye-facing projector sends near-infrared light toward the implanted chip. The implant converts that light into electrical signals that stimulate the remaining retinal cells. The official product description identifies the chip as approximately 2 by 2 millimeters.
Rehabilitation is part of the system
Patients undergo vision rehabilitation after surgery to learn how to use the camera-and-projector system. The device is therefore not a standalone implant that works without training; its practical benefit depends on the surgery, the glasses and the rehabilitation program working together.
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How the three-year data fit earlier evidence
| Evidence | Participants and follow-up | Vision finding | Important limitation or safety finding |
|---|---|---|---|
| PRIMAvera three-year report, presented in 2026 | 38 enrolled; 18 evaluable for efficacy and 27 for safety at 36 months | Mean acuity approximately 20/460 to 20/120; 14 of 18 (78%) improved by at least two and three chart lines | No control group; only 18 of the original 38 contributed efficacy data at 36 months |
| Peer-reviewed NEJM report, 2025 | 38 enrolled; 32 completed the 12-month assessment | 26 of 32 (81%) achieved at least 0.2 logMAR of clinically meaningful improvement; multiple-imputation analysis estimated 80% of all participants would meet that threshold | Twenty-six serious adverse events occurred in 19 participants, including 21 within two months after surgery |
| Five-patient feasibility study | 5 patients followed for 48 months | Mean improvement of 32 ETDRS letters with zoom (95% confidence interval, 13.4 to 49.9; P<0.0001) | No significant decline in natural peripheral visual function during follow-up; the sample was very small |
Together, these reports show a consistent signal across different follow-up periods, but they do not establish how PRIMA compares with another treatment in a randomized study. The five-patient study is especially useful for longer follow-up but cannot estimate typical results for the broader GA population.
Risks reported so far
Surgery was the main period of risk in the early experience. In the 12-month NEJM report, 26 serious adverse events occurred in 19 participants, and 21 of those events happened within two months after surgery. The three-year report states that most serious complications also occurred during the first postoperative year and were linked to the operation.
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Between months 13 and 36, three serious ocular adverse events were reported. The available three-year summary does not identify those events individually, so patients should ask a retinal surgeon for the complete safety profile and the risks that apply to their own eye condition.
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Who may be able to receive PRIMA in Europe?
The manufacturer states that PRIMA is indicated in the European Union for severely sight-impaired adults with geographic atrophy caused by dry AMD. Eligibility is determined through an assessment by a retinal specialist, not by visual-acuity numbers alone.
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- Confirm the diagnosis and cause of vision loss. A retinal specialist must establish that the severe impairment is associated with GA from dry AMD and assess whether enough retinal tissue remains for stimulation.
- Discuss surgical and device requirements. The consultation should cover subretinal implantation, use of the proprietary glasses and the need for postoperative rehabilitation.
- Ask about an authorized center. The manufacturer provides a specialist-finder pathway. Availability, waiting times, reimbursement and the complete list of participating clinics were not published in the available reports.
CE marking was reported in July 2026. The manufacturer says PRIMA has not received market approval outside the EU/EEA, and the device does not have US regulatory approval. A person in the United States therefore cannot assume that the European indication permits clinical access there.
How to judge PRIMA against other GA approaches
PRIMA is designed to restore a degree of lost central visual function, whereas other GA strategies may aim only to slow progression. A meaningful comparison should examine:
- Whether the approach restores central vision or primarily slows further loss.
- The size and durability of measured acuity changes.
- Surgical, implant-related and device-related risks.
- Whether remaining peripheral vision is preserved.
- Dependence on proprietary glasses, external equipment and rehabilitation.
- Regulatory status and geographic access.
- Evidence quality, including the presence of a control group, sample size and completeness of follow-up.
On those criteria, PRIMA has a documented three-year durability signal and a longer five-patient feasibility follow-up, but its principal three-year report remains uncontrolled and has substantial attrition.
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Quick Recap
What patients should ask before pursuing evaluation
- Am I within the European indication for severe sight impairment from GA caused by dry AMD?
- What surgical complications were seen at this center, and how often did they occur?
- What rehabilitation schedule and equipment will I need after implantation?
- How will my natural peripheral vision and fellow eye be monitored?
- Which costs are covered, and what reimbursement rules apply in my country?
- What alternatives are available if I cannot use the glasses or do not achieve useful vision?
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