Assessing PRIMA’s Efficacy and Safety at 36 Months

PRIMAvera 36-Month Results Presented at the 2026 AAO Meeting

Overview

At the 2026 American Academy of Ophthalmology meeting, Ehsan Rahimy, MD, reported 36-month PRIMAvera results in patients with advanced, end-stage geographic atrophy (GA): mean visual acuity improvement was approximately 30 ETDRS letters. The study reported 29 serious adverse events (SAEs), 83% of which occurred during the first 6 months after surgery; the presenter said events were managed and did not preclude visual gains.

Background

Geographic atrophy is an advanced form of age-related macular degeneration associated with substantial central vision loss. The PRIMA system is a subretinal photovoltaic implant designed to stimulate retinal cells using near-infrared light delivered by augmented-reality glasses. In the PRIMAvera study, 38 patients with advanced end-stage GA were enrolled across more than 17 European clinical sites; their average baseline visual acuity was described as equivalent to 20/460. The report presents extended efficacy and safety observations through 36 months following subretinal implant surgery.

Data Highlights

Measure	Reported result
PRIMAvera enrollment	38 patients
Baseline mean visual acuity	Equivalent to approximately 20/460
Mean ETDRS letter gain at 12 months	25 letters
Mean ETDRS letter gain at 36 months	Approximately 30 letters
Serious adverse events during study	29
SAEs occurring in first 6 months after surgery	83%
Patients with an SAE who achieved at least 15 ETDRS letters of gain	Almost two-thirds

Key Findings

The PRIMA implant is a 2 × 2 mm, 30-µm-thick subretinal photovoltaic chip with 378 pixels; it has no wires or battery and is used with augmented-reality glasses.
The device converts near-infrared light into electrical stimulation of bipolar and ganglion cells, using the retina’s native signaling structure, as described by the presenter.
Among 38 PRIMAvera participants with advanced end-stage GA, mean visual acuity improvement was 25 ETDRS letters at 12 months and approximately 30 letters at 36 months.
Twenty-nine SAEs were reported over the study, and 83% occurred within 6 months after surgery.
The presenter reported that SAEs were managed and did not compromise participants’ natural vision with the device off relative to their existing vision or fellow-eye performance over 3 years.
Almost two-thirds of participants who experienced an SAE achieved at least 15 ETDRS letters of visual gain, according to the presentation.

Clinical Implications

At the 2026 AAO meeting, Ehsan Rahimy, MD, reported mean visual acuity gains of approximately 30 ETDRS letters at 36 months in the PRIMAvera study. He reported 29 serious adverse events, 83% of which occurred during the first 6 months after surgery, and said the events were managed. He also reported that experiencing an SAE did not preclude visual acuity gain.

Conclusion

At the 2026 AAO meeting, Ehsan Rahimy, MD, reported approximately 30 ETDRS letters of mean visual acuity gain at 36 months in PRIMAvera and said that 83% of the 29 reported serious adverse events occurred during the first 6 months after surgery.