PRIMA retinal implant restores vision in patients with advanced GA

An editorial published in the New England Journal of Medicine¹ referred to the Photovoltaic Retina Implant Microarray (PRIMA) Implant (Science Corporation) as “the first treatment to restore vision” in patients with advanced geographic atrophy (GA) associated with age-related macular degeneration (AMD).

The editorial highlights the study by Holz and colleagues² printed in the same issue of the journal. The authors reported the 12-month results achieved in patients with severe visual loss from GA secondary to AMD.

The editorial was authored by Jacque L. Duncan, MD, professor of ophthalmology and chair of the Department of Ophthalmology, University of California, San Francisco, who did not participate in the PRIMA study.

In a press release issued by Science Corporation, the company described the implant as “consisting of a tiny wireless chip implanted in the retina combined with a pair of special glasses, based on work conducted by Professor Daniel Palanker at Stanford University.”

PRIMA study methodology and results

A total of 38 patients were included in the study. All underwent implantation of the PRIMAretinal prosthetic chip with the goal of restoring vision.

Holz and colleagues conducted an international, open-label, multicenter, prospective, single-group, baseline-controlled clinical study. All patients had GA and a minimum visual acuity of at least 1.2 of the minimum angle of resolution. The patients underwent assessment of their vision with and without PRIMA glasses at 6 and 12 months. Holz, the first study author, is a professor and chairman of the Department of Ophthalmology at the University of Bonn, Germany.

The primary study end points were a clinically meaningful improvement in visual acuity (≥0.2 logMAR) from baseline to month 12 after implantation and the number and severity of serious adverse events related to the procedure or device through month 12, the authors recounted.

PRIMA implant. (Image courtesy Science Corporation)

Of the 38 enrolled patients who received the implant, the investigators were able to assess 32 patients at the 12-month follow-up time point. Six patients were not assessed because three had died, one withdrew, and two were not available to be tested.

Holz and colleagues reported, “Among the 32 participants who completed 12 months of follow-up, the PRIMA system led to a clinically meaningful improvement in visual acuity from baseline in 26 (81%; 95% confidence interval, 64 to 93; P<0.001).

Using multiple imputation to account for the six participants who had not been assessed, the investigators estimated that “80% (95% CI, 66 to 94; P<0.001) of all participants would have had a clinically meaningful improvement at 12 months,” they reported.

The authors reported 26 serious adverse events in 19 patients. Of those, the majority (81%) occurred within 2 months postoperatively, and 20 (95%) resolved within 2 months after development.

“In this study involving 38 participants with GA due to AMD, the PRIMA system restored central vision and led to a significant improvement in visual acuity from baseline to month 12,” the authors concluded.

The study was funded by Science Corporation and Moorfields National Institute for Health and Care Research Biomedical Research Centre; PRIMAvera ClinicalTrials.gov (NCT04676854).

The company reports having applied for regulatory approval in Europe with the hope of the implant becoming available later in 2026. In the US, the FDA approval process is underway.

References

1. Duncan J. Behind the science: restoring vision for patients with AMD and geographic atrophy. N Engl J Med. 2026;394:298-301. Published January 14; DOI: 10.1056/NEJMe25145922. Holz FG, Le Mer Y, Muqit MMK, et al. Subretinal photovoltaic implant to restore vision in geographic atrophy due to AMD. Published online on October 20, 2025; N Engl J Med. 2026;394:232-242.

2. Holz FG, Le Mer Y, Muqit MMK, et al. Subretinal photovoltaic implant to restore vision in geographic atrophy due to AMD. Published online on October 20, 2025; N Engl J Med. 2026;394:232-242.