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Science Corp's PRIMA implant patients averaged a 29-letter vision gain at three years

Three years after surgery, the 18 patients still being assessed in the pivotal trial of Science Corporation’s PRIMA retinal implant could read on average 29 more letters on an eye chart than before they were implanted. All had lost their central vision to advanced age-related macular degeneration. Science reported the 36-month results on 5 October, about 11 weeks into the implant’s commercial launch in Europe.

The three-year numbers

PRIMA is a 2-millimetre wireless chip placed under the retina, paired with glasses that project near-infrared light onto it. It stands in for light-sensing cells lost to geographic atrophy, the advanced stage of dry age-related macular degeneration. The pivotal PRIMAvera trial implanted 38 patients at 17 sites in five European countries.

At 36 months, the 18 patients assessed for vision read on average 29 more letters on a standard eye chart than before surgery, close to six lines. At 12 months, the 32 patients then assessed had gained 24.5 letters with PRIMA glasses and 25.5 letters with the setting of their choice. Science has not said which setting the 36-month figure uses. Of the 18 patients, 14 (78 percent) had gained at least 15 letters, matching the 78 percent (25 of 32) in a post hoc analysis of the 12-month data. Natural vision in the implanted eye held steady, and repeated imaging showed the implant site stable.

No new safety signal appeared between months 12 and 36. Serious adverse events clustered in the first six months after surgery, and three occurred after month 12. Through month 12, the trial recorded 26 serious adverse events in 19 participants that its safety monitoring board judged related to the procedure or device; all were linked to the surgery alone or to the surgery and the device together, and none to the device alone.

“Three years after implantation, the patients who gained vision have kept it, even improved it,” said Mahi Muqit, a consultant vitreoretinal surgeon at Moorfields Eye Hospital, who presented the results in a late-breaking session at the EURETINA congress in Vienna. Science chief executive Max Hodak said: “In clinical trials, PRIMA is working better at month 36 than it did at month six.”

Who was still being counted

Of the 38 patients implanted, 27 were evaluable for safety at 36 months and 18 for vision. At 12 months, 32 were assessed; of the six missing then, three had died, one had withdrawn and two were unavailable for testing. The 36-month averages describe the 18 patients still assessed for vision, just under half of those implanted, so they may not reflect the outcome for every patient who received the device.

Why durability matters for the commercial case

PRIMA went on sale in Europe in July 2026 under a CE mark and is now also available in the UK. It is pending FDA approval in the United States. For a device implanted under the retina of older patients, health systems paying for it and US regulators weighing it need evidence that the benefit lasts and that late complications stay rare. The three-year pivotal data are early evidence on both, from 18 patients for vision and 27 for safety, and are not yet peer reviewed.

Science manufactures the current implant, which Daniel Palanker originally developed at Stanford, and is designing a next version with higher resolution and a wider field of view.

The ‘first’ claim

Hodak called the results “the first multi-year durability data for a BCI that restores form vision.” Earlier multi-year data exist. A five-patient feasibility study of PRIMA in Paris published four-year letter-reading results in 2024, with three patients assessed, who had gained an average of 32 letters using the system’s zoom. Second Sight’s Argus II, an implant for a different disease, retinitis pigmentosa, published five-year results from its clinical trial in 2016.

Not disclosed

Why patients left the vision assessment between 12 and 36 months is not disclosed. Individual results for the 18 patients are not public, and the 36-month data have not yet appeared in a peer-reviewed journal. How many commercial PRIMA implants have been performed since the July launch, and at what price, is not disclosed. Science has not given a date for an FDA decision.

What to watch

Whether the 36-month results are published in a peer-reviewed journal, with reasons for each patient lost to follow-up.

Whether the FDA approves PRIMA, which would open the US market to the device.

Whether European health systems agree to pay for PRIMA, and how many implants Science reports in its first year on sale.

Whether the next-generation implant enters a clinical trial.

Sources

Primary:

Cross-reference to prior InsideBCI coverage:

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