Objective:
Report three-year efficacy and safety findings from the PRIMAvera trial of the PRIMA subretinal photovoltaic implant in patients with geographic atrophy.
Approach:
- Study: PRIMAvera enrolled 38 patients at 17 centers across Europe. After implantation, participants completed vision rehabilitation to learn to use the system.
- Assessment: The 2026 AAO meeting presentation reported outcomes through 36 months. At that point, 18 patients were evaluated for efficacy and 27 for safety.
Key Findings:
- Among 18 patients assessed at three years, average vision with the device was about 20/120, compared with roughly 20/460 at study start.
- Fourteen of 18 patients (78%) improved by at least two lines; the same proportion improved by at least three lines.
- With the device switched off, vision in implanted eyes remained essentially unchanged over three years; vision in untreated eyes continued to decline.
- Three patients each experienced one serious eye-related adverse event between months 13 and 36. Most serious complications occurred in the first year and were linked to surgery.
Interpretation:
The reported gains in vision with the device were maintained through 36 months among the patients evaluated.
Limitations:
- 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 others were not assessed.
Conclusion:
Study lead author Joseph Martel said the 12-month gains persisted through 36 months and expressed interest in seeing the results replicated in real-world use.
Sources:
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