Objective:

The article examines the objective, findings, and clinical context described in Assessing PRIMA’s Efficacy and Safety at 36 Months.

Approach:

• Device and procedure: The 2 × 2 mm, 378-pixel photovoltaic chip is implanted beneath the retina during vitrectomy. Augmented-reality glasses deliver near-infrared light to the chip, which stimulates retinal cells.
• Study population: The PRIMAvera trial enrolled 38 patients at more than 17 European sites; participants had advanced, end-stage geographic atrophy and mean baseline visual acuity equivalent to approximately 20/460.

Key Findings:

• Mean visual acuity gain was approximately 25 ETDRS letters at 12 months and approximately 30 letters at 36 months.
• The study reported 29 serious adverse events; 83% occurred within the first 6 months after surgery.
• The presenter reported that adverse events were managed and did not worsen patients’ natural vision with the device off relative to their existing vision or fellow-eye performance over 3 years.
• Nearly two-thirds of patients who experienced a serious adverse event gained at least 15 ETDRS letters.

Interpretation:

The presenter described visual acuity gains through 36 months and a safety profile in which most serious adverse events occurred early after surgery. Serious adverse events did not preclude substantial visual gains in many affected patients.

Limitations:

• The account does not provide detailed adverse-event types, severity, or individual event rates.
• The findings are reported in a meeting presentation transcript; no statistical analyses or full study report are provided in the supplied context.

Conclusion:

The presenter reported sustained visual acuity improvement and manageable serious adverse events through 36 months in the PRIMAvera study.

Sources:

• Provided article context: presentation by Ehsan Rahimy, MD, at the 2026 AAO Meeting