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Freedom251 › Blog › dry age-related macular degeneration

PRIMA Retinal Implant Vision Gains Persist at Three Years in European Geographic Atrophy Trial

By Freedom251 Team · · 5 min read

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Yes—among participants who could be assessed at 36 months, vision gains from the PRIMA retinal implant were still present. In the European PRIMAvera trial, mean visual acuity improved from about 20/460 before implantation to about 20/120 after three years. Fourteen of 18 evaluable patients (78%) gained at least two chart lines, and the same 14 gained at least three. The result is encouraging for people with severe central vision loss from geographic atrophy (GA), but it is not yet proof from a randomized, controlled study: only 18 of the original 38 participants contributed three-year efficacy data.

What the three-year PRIMAvera results show

PRIMAvera enrolled 38 adults at 17 European centers. At the 36-month visit, investigators had efficacy data for 18 participants and safety data for 27. The findings were presented at the 2026 American Academy of Ophthalmology meeting.

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Measure Finding How to interpret it
Mean visual acuity Approximately 20/460 at baseline to approximately 20/120 at 36 months A large average improvement, although 20/120 remains substantially impaired vision
Improvement of at least two chart lines 14 of 18 patients (78%) Most evaluable patients reached the study’s two-line threshold
Improvement of at least three chart lines 14 of 18 patients (78%) The same patients met the more demanding three-line threshold
Three-year efficacy sample 18 of 38 enrolled participants Results may not represent every person originally treated
Three-year safety sample 27 participants Safety follow-up was more complete than efficacy follow-up, but still not available for all 38

When the implant was switched off, residual vision in the implanted eyes stayed essentially unchanged over the three-year period. Untreated fellow eyes continued to decline. That pattern is consistent with a device-related functional benefit rather than a simple change in the underlying atrophy, but the absence of a control group means the study cannot establish comparative effectiveness.

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Joseph Martel, MD, the lead author, said the gains seen at 12 months “persisted through 36 months.” The report should therefore be read as a durability signal: patients who responded early generally retained that improvement through three years, within the limits of the follow-up data.

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How PRIMA creates an image

PRIMA is a combined implant-and-glasses system rather than a stand-alone retinal chip.

  1. A front-facing camera in the proprietary glasses captures the scene in front of the wearer.
  2. An eye-facing projector sends the visual information as near-infrared light toward the subretinal implant.
  3. The implant’s 378 photovoltaic pixels convert that light into electrical signals.
  4. Those signals stimulate surviving retinal neurons, which send information through the remaining visual pathway.
  5. After surgery, patients complete vision rehabilitation to learn how to align, interpret and use the artificial central image.

The implant is described as a roughly 2-by-2-millimeter chip. Because it stimulates surviving neurons instead of replacing the entire retina, the system is intended for people whose photoreceptors have been lost but whose downstream retinal circuitry can still respond.

What earlier studies add

Twelve-month peer-reviewed results

The peer-reviewed 12-month report included all 38 participants at enrollment; 32 completed the one-year assessment. Twenty-six of those 32 (81%) achieved a clinically meaningful improvement of at least 0.2 logMAR. A multiple-imputation analysis, which estimates outcomes for participants without a complete visit, projected that 80% of all enrolled participants would meet that threshold.

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The same report documented 26 serious adverse events in 19 participants. Twenty-one events occurred within two months of surgery, showing that the highest complication burden was concentrated in the early postoperative period.

Forty-eight-month feasibility follow-up

A separate feasibility study of five patients reported a mean improvement of 32 ETDRS letters with zoom at 48 months (95% confidence interval, 13.4 to 49.9; P<0.0001). Investigators found no significant decline in natural peripheral visual function during follow-up. Because only five people were studied, those results support long-term feasibility but cannot establish how often the benefit occurs in a wider population.

Risks and limitations of the three-year evidence

Incomplete efficacy follow-up

The most important limitation is attrition: three-year efficacy analysis covered 18 of 38 participants. Reasons for missing efficacy assessments and the outcomes of every non-evaluable participant are not supplied in the three-year summary. A response rate calculated from 18 people should not be presented as a response rate for all 38 enrollees.

No randomized control group

PRIMAvera did not randomize participants to an implant or comparison treatment. The continuing decline in untreated fellow eyes provides useful context, but fellow-eye comparisons can be affected by differences between eyes and do not replace a matched control group.

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Surgical and device-related complications

Most serious complications occurred during the first postoperative year and were linked to surgery. Three serious ocular adverse events occurred between months 13 and 36. The three-year report does not establish that the implant prevents progression of GA in the untreated retina, nor does it show that every patient can achieve functional reading or face-recognition vision.

What the acuity numbers do—and do not—mean

Moving from approximately 20/460 to 20/120 is clinically meaningful, but it is not restoration to normal 20/20 sight. Individual results varied, and the average does not predict the outcome for a particular eye. Rehabilitation, correct use of the glasses and the amount of surviving retinal circuitry all affect practical performance.

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Who can receive PRIMA in Europe?

The manufacturer states that PRIMA is indicated in the European Union for severely sight-impaired adults with geographic atrophy caused by dry age-related macular degeneration. Eligibility is determined by a retinal specialist, not by a self-screening checklist. A specialist must confirm the diagnosis, severity, retinal anatomy, surgical suitability and the ability to participate in postoperative rehabilitation.

  1. Obtain a retinal examination confirming GA from dry AMD and documenting the extent of central vision loss.
  2. Ask whether an implanting center is accepting evaluations and whether the eye meets current anatomical and functional criteria.
  3. Review the surgical risks, expected visual goals, glasses requirements and rehabilitation schedule.
  4. Discuss how existing peripheral vision and the fellow eye may support daily activities during recovery.

PRIMA received CE marking in July 2026, according to Eyewire. The manufacturer says it has not received market approval outside the EU/EEA. It therefore does not have US regulatory approval, and access in the United States should not be assumed.

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How to compare PRIMA with other GA approaches

Patients and clinicians should compare strategies on the dimensions that matter for daily function, not on a single headline percentage:

  • Goal: PRIMA is designed to restore some central visual function; other approaches may primarily slow disease progression.
  • Magnitude and durability: examine the measured acuity change, the proportion reaching a prespecified line or letter threshold and how long follow-up is available.
  • Risk: weigh vitrectomy and implantation risks, later ocular events, device failure and the possibility of additional procedures.
  • Peripheral vision: ask whether natural peripheral function was preserved and how it was measured.
  • Daily-use requirements: PRIMA requires proprietary camera glasses and structured rehabilitation.
  • Evidence quality: check whether a study has a control group, how many participants remain at each follow-up and whether missing data could change the result.
  • Access: confirm the regulatory status in the patient’s country and whether an experienced retinal center is available.

What is still unknown

Publicly reported sources do not establish PRIMA’s price, reimbursement terms or a complete list of European clinics. Those details must be confirmed directly with an authorized retinal center and the relevant health system. The three-year findings also do not answer how performance changes beyond 36 months, how consistently patients use the glasses in everyday settings or which baseline retinal features best predict a strong response.

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dry age-related macular degenerationgeographic atrophyophthalmologyPRIMA retinal implantretinal prosthesisvision restoration

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