Devices

Subretinal 378-pixel photovoltaic implant with near-infrared camera glasses for geographic atrophy, with a 38-participant European study published in NEJM in October 2025.

Catalog specification sheet - Other

Science PRIMA subretinal photovoltaic implant

Record ID
BTSD-STUP-0004
Reviewed
2026-10-08
Interface
other
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

Science PRIMA subretinal photovoltaic implant

PRIMA is a 2 x 2 mm, 30 um thick silicon implant of 378 photovoltaic pixels placed under the retina and driven by 880 nm light from camera glasses. This sheet uses the open-access NEJM paper. Regulatory status beyond the trial is not verified here.

Identity

FieldValue and source scope
DeviceScience Corporation PRIMA system: subretinal photovoltaic implant, glasses with camera and near-infrared projector, and a pocket processor [1]
ManufacturerScience Corporation, Alameda, California [1][2]
Interface classSubretinal photovoltaic retinal prosthesis, wirelessly activated by light [1]
OriginCompany device; the paper reports a multicenter study at 17 sites in 5 European countries [1]
First demonstratedUnreported
First human implantUnreported
Species studiedHuman [1]
Regulatory statusInvestigational in the NEJM trial; the NEJM paper reports a confirmatory study, and company statements about regulatory submissions were not verified here [1][2]
FunctionRestores central vision in geographic atrophy due to age-related macular degeneration [1]
Target tissueSubretinal space under the atrophic lesion [1]

Geometry and architecture

FieldValue and source scope
Interface typeCrystalline silicon array implanted subretinally within the atrophic lesion [1]
Array layout378 photovoltaic pixels, each 100 um [1]
Electrode count378 pixels [1]
PitchPixel size 100 um (pitch not separately stated in the text read) [1]
Electrode lengthsUnreported
Shank width and thicknessImplant 2 x 2 mm wide and 30 um thick [1]
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodUnreported
Anchoring and fixationUnreported

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialUnreported
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityUnreported
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsUnreported
Data pathA frame-mounted camera captures images; processed images are projected onto the implant with 880 nm near-infrared light [1]
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerImplant pixels convert the near-infrared light into electrical current; no implanted battery [1]
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilityUnreported
Surgical complexityUnreported
Output connectorsUnreported

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsUnreported
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsPRIMAvera: 38 participants implanted, 17 sites in 5 European countries; 32 reached 12 months; mean age 78.9; an earlier feasibility trial had 5 participants [1]
Preclinical cohortUnreported
Follow-up duration12 months [1]
IndicationsGeographic atrophy from AMD, age 60 or older, visual acuity logMAR 1.2 or worse, fovea-involving atrophy larger than 2.4 mm [1]
Trials and registriesNCT04676854 PRIMAvera: open-label, baseline-controlled, single-arm, multicenter. Published N Engl J Med 2025 Oct 20;394(3):232-242 [1]
Primary outcomes26 of 32 (81.3%; 95% CI 63.56 to 92.79) improved visual acuity by at least logMAR 0.2 at 12 months; with glasses, mean improvement logMAR 0.49 (about 24.5 letters). Prosthetic acuity logMAR 1.32 (20/417), matching the 100 um pixel sampling limit [1]
Key limitationsSingle-arm, open-label. 26 serious adverse events in 19 participants, 81% within the first two months. Three of the six who did not reach 12 months died. Mean atrophy area grew 8.5 mm2 in study eyes versus 2.5 mm2 in fellow eyes [1]

Engineering tradeoffs

FieldValue and source scope
StrengthsUnreported
LimitationsUnreported
Scaling constraintsUnreported

Version boundary

The implant and glasses as used in the PRIMAvera trial.

References

  1. N Engl J Med 2025;394(3):232-242, subretinal photovoltaic implant (PMC full text).
  2. Science Corporation release on the NEJM paper.