Retinal Implant For Geographic Atrophy Shows Evidence Of Durable Control

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In results presented at the American Academy of Ophthalmology meeting, the PRIMA retinal implant was associated with sustained central-vision improvement through 36 months among people with advanced geographic atrophy. The study was a single-arm trial: 27 of 38 participants completed three-year follow-up, and the findings do not establish how the device compares with other care.

People with advanced geographic atrophy who received the wireless PRIMA retinal implant continued to show device-assisted central-vision gains through 36 months, according to results presented by Stanford Medicine ophthalmologist Ehsan Rahimy at the American Academy of Ophthalmology annual meeting. The update adds two years of follow-up to earlier results, but comes from a single-arm study and does not show how the device compares with an untreated or alternative-treatment group.

The PRIMAvera study enrolled 38 patients at 17 sites in Europe, all with advanced geographic atrophy, a late form of dry age-related macular degeneration that damages the central retina. At 36 months, 27 participants had completed follow-up. Rahimy described the trial as a phase III-equivalent pivotal study; its primary endpoints covered safety and efficacy, with efficacy defined as a clinically meaningful visual-acuity improvement of at least 0.2 logMAR.

Among the reported vision results, average visual acuity with device assistance was -0.59 logMAR at 36 months, described as a gain of about 30 letters and about five letters better than the 12-month result. The report also said vision without device assistance in the implanted eye remained stable, while the untreated eye lost about 1.4 lines. These measures describe different aspects of vision and should not be read as a comparison between treatment groups.

More than 80% of patients reported being able to read letters, numbers and words at 12 months. Between months 24 and 36, half reported performing more advanced tasks, including using a smartphone, reading a menu and playing cards. These are patient-reported abilities, and the report does not provide a control group for judging how much of the change was attributable to the implant alone.

Investigators recorded 29 serious adverse events over three years; 24 occurred in the first six months. Reported events included hypotony, subretinal hemorrhage, minor retinal tears and macular holes. Rahimy said the events did not compromise patients’ natural vision, and that 68% of patients who experienced a serious adverse event still gained more than 15 letters with device assistance. That figure is a study finding, not a guarantee for individual patients.

A Potential Route to Central Vision

Geographic atrophy can destroy central vision, making tasks such as reading and recognizing detail difficult. The PRIMA results matter because they suggest that an implanted system may provide usable central vision for several years in some people with advanced disease, while the report says natural peripheral vision is preserved. The everyday activities reported by participants offer a practical measure alongside eye-chart scores.

The findings remain an early evidence base for decisions about wider use. Because PRIMAvera had no comparison group and only 27 of 38 participants reached the 36-month assessment, the results cannot by themselves establish comparative effectiveness, the likelihood of benefit for a new patient, or how the device performs across a broader population. The balance of functional gains, surgery-related risks and the demands of device training will matter to patients and clinicians.

How the PRIMA System Works

PRIMA is a wireless photovoltaic implant placed beneath the retina in an area affected by atrophy. It is designed to replace some lost photoreceptor function and stimulate retinal cells that send signals toward the brain. Patients wear augmented-reality glasses with a camera; a processor converts the captured image into pulsed near-infrared light, which reaches and powers the implant.

The wearer can adjust settings such as brightness and zoom. Rahimy cautioned that vision does not return simply by switching on the system: patients undergo a postoperative training process to learn how to use it. The presentation updates 12-month results reported at the prior year’s AAO meeting. The report said the device received approval in Europe in July, but did not give a year or sales figures. Rahimy said the manufacturer, Science Corporation, was on track to seek U.S. Food and Drug Administration approval.

“The PRIMA system produced durable, clinically meaningful restoration in central vision in patients with geographic atrophy, extending through 36 months.”

— Ehsan Rahimy, MD, Stanford Medicine

Follow-Up and Comparison Gaps

Seven participants died during the study, and investigators did not consider the deaths related to the implant or surgery. Miller said a comparison population could help put the number in context. Rahimy responded that participants had bilateral, end-stage geographic atrophy and a mean age of about 79. The report does not provide enough information to assess the mortality observation against a matched group. Four other participants left follow-up after relocating or being unable to continue, according to Rahimy.

It is also unclear from the reported results how durable the benefits will be beyond three years, how outcomes compare with other care, and what the device’s longer-term safety profile will be in broader use. Rahimy said he had no information on European sales or possible safety issues after approval. The study’s participant-reported task results and visual-acuity measures do not establish the degree of benefit every patient should expect.

Regulatory Review and Longer Follow-Up

Science Corporation is expected to pursue FDA review, according to Rahimy, but the report gives no filing date, review timetable or decision. Any U.S. regulatory assessment would need to consider the trial’s efficacy findings, surgical risks and duration of follow-up.

Further data will be needed to clarify longer-term outcomes and real-world use, including training requirements and safety after European approval. The available report does not specify when additional results will be released. Until more comparative and follow-up evidence is available, the three-year findings show sustained improvement among study participants, not a settled estimate of benefit for all people with geographic atrophy.

Key Questions

What is the PRIMA retinal implant?

PRIMA is a wireless photovoltaic implant placed beneath the retina. It works with augmented-reality glasses and a processor that sends near-infrared light to the implant, which stimulates retinal cells.

What did the study report at 36 months?

The study reported average device-assisted visual acuity of -0.59 logMAR at 36 months, described as about a 30-letter gain. The results came from a single-arm study, and 27 of the 38 original participants completed three-year follow-up.

Did the implant stop geographic atrophy?

The report describes vision outcomes and says the implant provides central-vision restoration in areas of retinal atrophy. It does not establish that the device stops or reverses the underlying geographic atrophy.

What safety events were reported?

Investigators recorded 29 serious adverse events during the three-year study, with 24 occurring in the first six months. Reported events included hypotony, subretinal hemorrhage, retinal tears and macular holes; the report says investigators did not consider the seven deaths related to the implant or procedure.

Is PRIMA available in the United States?

The source report said the device had received approval in Europe in July and that the manufacturer was on track to seek FDA approval. It did not provide a U.S. filing date or approval decision.

Source: rss