Three-Year Data Show Vision Gains Maintained With Subretinal Implant

Clinical Report: Three-Year Data Show Vision Gains Maintained With Subretinal Implant

Overview

At the 2026 American Academy of Ophthalmology meeting, investigators reported that visual acuity gains with the PRIMA subretinal photovoltaic implant were maintained through 36 months in patients with geographic atrophy. Among 18 patients evaluated for efficacy at 3 years, 14 (78%) improved by at least 2 lines; device-off vision in implanted eyes remained essentially unchanged. The study had no control group, and 18 of the original 38 participants were evaluable for efficacy at 36 months.

Background

Geographic atrophy is an advanced form of age-related macular degeneration associated with progressive central vision loss. The PRIMA system uses a subretinal photovoltaic implant and camera-equipped glasses to deliver visual signals to surviving retinal cells, with rehabilitation to help patients use the system. The 2025 report of the PRIMAvera trial described visual acuity improvement at 6 and 12 months in a single-group study. Current AAO guidance addresses geographic atrophy through risk modification, appropriate AREDS2 supplementation, monitoring, low-vision resources, and evidence on treatments that slow lesion growth.

Data Highlights

Measure	Reported result
PRIMAvera enrollment	38 patients at 17 centers across Europe
Mean vision at study start	Approximately 20/460
Patients evaluable for efficacy at 36 months	18 of 38
Mean vision with device at 3 years	Approximately 20/120
Improved by at least 2 lines	14 of 18 patients (78%)
Improved by at least 3 lines	14 of 18 patients (78%)
Patients evaluable for safety at 36 months	27 of 38
Serious eye-related adverse events, months 13–36	Three patients, one event each

Key Findings

PRIMAvera enrolled 38 patients with geographic atrophy at 17 European centers; participants received vision rehabilitation after implantation.
Among 18 patients assessed for efficacy at 36 months, mean vision with the device was approximately 20/120, compared with approximately 20/460 at study start.
Fourteen of 18 patients (78%) improved by at least 2 lines, and the same proportion improved by at least 3 lines.
With the device switched off, vision in implanted eyes remained essentially unchanged over 3 years; vision in untreated eyes continued to decline as the disease progressed.
Three patients each experienced one serious eye-related adverse event between months 13 and 36; the article reports that most serious complications occurred in the first year and were linked to surgery.
The trial had no control group. At 36 months, 27 of 38 participants were evaluable for safety and 18 for efficacy; the summary did not state why the remaining participants were not assessed.

Clinical Implications

The reported results describe sustained device-associated visual acuity gains in the subset of PRIMAvera participants evaluated at 36 months, alongside stable device-off vision in implanted eyes. The findings are from a trial without a control group and with fewer participants evaluated for efficacy than originally enrolled; the source does not establish comparative effectiveness or explain all missing follow-up assessments.

Conclusion

The 2026 meeting update reports that visual acuity gains with the PRIMA implant persisted through 3 years among evaluated participants with geographic atrophy. Interpretation is limited by the single-group design and the number of participants assessed at 36 months.