Retinal biomarkers for neurodegenerative disease

01Overview and value chain

Markers: [EC: IVDR 2017/746 | OECD: Biotech-health | Regulator: FDA (USA), EMA (European Union), NMPA (China)]

Retinal biomarkers for neurodegenerative disease use eye-scan technologies to detect signals of Alzheimer’s and related conditions directly in retinal tissue, exploiting the retina’s direct neural and vascular connection to the brain as a non-invasive, accessible proxy for pathology that would otherwise require PET imaging or cerebrospinal-fluid sampling. RetiSpec’s AI-driven hyperspectral eye test analyzes subtle spectral signatures in retinal tissue associated with Alzheimer’s disease, with the company recently closing a $10 million USD round to advance commercialization and its underlying hyperspectral-imaging technology documented in a dedicated patent filing. Optina Diagnostics develops a related hyperspectral retinal-imaging approach for Alzheimer’s biomarker detection, co-published in the same multi-site Alzheimer’s Research & Therapy study and running an active registered clinical trial. Heidelberg Engineering’s Spectralis OCT platform, an established retinal-imaging system originally built for ophthalmology, is now widely used as a research and clinical tool for OCT-based structural and vascular biomarkers linked to neurodegenerative disease, documented across multiple 2026 publications including JAMA Ophthalmology. NeuroVision Imaging’s retinal amyloid-imaging technology targets amyloid-beta deposits detectable in the retina, part of the same expanding multi-site research literature validating retinal biomarkers against established Alzheimer’s diagnostic measures.

The key directions of retinal biomarkers for neurodegenerative disease are:

1. Hyperspectral retinal imaging (Hyperspectral Retinal Imaging): capturing a full spectral signature (not just a color image) of retinal tissue to detect subtle Alzheimer’s-associated changes invisible to conventional imaging — RetiSpec, Optina Diagnostics.
2. OCT-based neurodegenerative biomarkers (OCT Neurodegenerative Biomarkers): optical coherence tomography measuring retinal nerve fiber layer thickness and vascular density as structural proxies for neurodegeneration — Heidelberg Engineering’s Spectralis platform.
3. Retinal amyloid imaging (Retinal Amyloid Imaging): detecting amyloid-beta deposits directly in retinal tissue, mirroring the amyloid pathology central to Alzheimer’s diagnosis — NeuroVision Imaging.
4. AI-driven multi-site biomarker validation (AI Retinal Biomarker Validation): machine-learning classifiers trained and validated across multi-site clinical studies to establish retinal-biomarker correlation with confirmed neurodegenerative-disease status.

Sectoral value chain

[retinal imaging technology development] ──> [multi-site clinical validation studies] ──> [regulatory clearance]
                                                    │
                                       (clinical/screening deployment)
                                                    │
                                                    ▼
[integration into neurodegenerative diagnostic pathway] <─── [AI biomarker classification & report] <─────┘

Value chain levels

Cross-cutting technologies of the sector:

• Hyperspectral imaging (Hyperspectral Retinal Imaging): capturing dozens to hundreds of spectral bands across the retina reveals tissue-composition changes invisible to standard RGB fundus photography, the core RetiSpec/Optina Diagnostics approach.
• Optical coherence tomography (OCT Neurodegenerative Biomarkers): high-resolution cross-sectional retinal imaging measures nerve fiber layer thinning and microvascular changes correlated with neurodegenerative disease progression.
• Retinal amyloid detection (Retinal Amyloid Imaging): imaging techniques targeting amyloid-beta deposits in retinal tissue provide a proxy for the amyloid plaque burden central to Alzheimer’s pathology.

02US

North America hosts the leading commercial-stage retinal-biomarker companies, spanning hyperspectral imaging and amyloid-specific detection technologies.

RetiSpec, NeuroVision Imaging, FDA

• RetiSpec: its AI-driven hyperspectral eye test analyzes retinal spectral signatures associated with Alzheimer’s disease, recently closing a $10 million USD funding round to advance commercialization, with the underlying imaging technology documented in a dedicated patent filing.
• NeuroVision Imaging: develops retinal amyloid-imaging technology targeting amyloid-beta deposits detectable in retinal tissue, part of the expanding multi-site research literature validating retinal biomarkers against confirmed Alzheimer’s diagnostic measures.
• FDA framework: retinal-biomarker imaging devices for neurodegenerative-disease detection remain predominantly in clinical-validation and research use, with FDA clearance requiring large multi-site studies correlating the retinal signal against PET or CSF-confirmed diagnosis.

03CN

No dedicated Chinese retinal-biomarker company for neurodegenerative disease cleared source confirmation as of 2026; the field’s research literature in this period centers on general neurodegenerative-biomarker market analysis rather than a specific commercial retinal-imaging originator.

research gap, NMPA pathway

• Research and literature focus: Chinese industry reporting on neurodegenerative biomarkers in 2026 covers the broader diagnostic-biomarker market rather than a retinal-imaging-specific commercial platform.
• NMPA pathway: any retinal-biomarker imaging device reaching Chinese clinical use would register with NMPA as a medical device, following the same validation-heavy pathway required in the US and EU given the early clinical-evidence stage of the category.

04EU

Germany anchors Europe’s contribution through Heidelberg Engineering, whose established OCT platform has become a widely used research and clinical tool for retinal neurodegenerative biomarkers.

Spectralis OCT, IVDR

• Heidelberg Engineering: its Spectralis OCT platform, originally built for ophthalmology, is now widely used as a research and clinical tool for OCT-based structural and vascular biomarkers linked to neurodegenerative disease, documented across multiple 2026 publications including JAMA Ophthalmology.
• IVDR/MDR framework: retinal-imaging devices sold in the EU require conformity assessment under the Medical Device Regulation (MDR 2017/745), with any paired diagnostic-software claim additionally subject to IVDR 2017/746.

05Leading companies and research institutes

06Tech stack and innovations

The stack applies three distinct optical principles to the same underlying goal — reading neurodegenerative-disease pathology out of retinal tissue non-invasively — hyperspectral signature analysis, structural/vascular OCT imaging, and amyloid-specific detection.

1. AI-driven hyperspectral analysis (Hyperspectral Retinal Imaging):
   • RetiSpec and Optina Diagnostics both capture full spectral signatures across the retina and apply machine-learning classifiers to detect subtle tissue-composition changes associated with Alzheimer’s disease, validated in shared multi-site clinical research.
2. OCT structural and vascular biomarkers (OCT Neurodegenerative Biomarkers):
   • Heidelberg Engineering’s Spectralis platform measures retinal nerve fiber layer thickness and microvascular density, structural proxies increasingly correlated with neurodegenerative disease progression in published clinical research.
3. Retinal amyloid detection (Retinal Amyloid Imaging):
   • NeuroVision Imaging’s technology targets amyloid-beta deposits in retinal tissue, mirroring the amyloid-plaque pathology central to Alzheimer’s diagnosis without requiring brain PET imaging.
4. Multi-site clinical validation (AI Retinal Biomarker Validation):
   • RetiSpec and Optina Diagnostics’ co-published, multi-site Alzheimer’s Research & Therapy study illustrates the category’s shared push toward large validated cohorts as the evidence bar for eventual regulatory clearance.

07Value chains and production pipelines

Industrial pipeline of a retinal neurodegenerative biomarker device (FDA 510(k)/PMA / EU MDR-IVDR)

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Imaging technology     │ ───> │ 2. Multi-site clinical    │
│    development              │      │    validation                │
└───────────────────────────┘      └───────────────────────────┘
                                                   │
                                                   ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Clinical/screening     │ <─── │ 3. Regulatory clearance   │
│    deployment                │      │                           │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. AI biomarker           │ ───> │ 6. Diagnostic pathway     │
│    classification            │      │    integration               │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Imaging technology development

The hyperspectral, OCT or amyloid-ligand imaging hardware and its retinal-specific optics are engineered to capture the target biomarker signal from a routine, non-invasive eye scan.

Stage 2: Multi-site clinical validation

The retinal-imaging signal is correlated against PET- or cerebrospinal-fluid-confirmed neurodegenerative-disease status across multiple study sites, the evidence base RetiSpec and Optina Diagnostics’ co-published research contributes to.

Stage 3: Regulatory clearance

The imaging device and its diagnostic claim undergo FDA 510(k)/PMA review or EU MDR/IVDR conformity assessment, with the category’s early clinical-evidence stage meaning most platforms remain in validation rather than full clearance as of 2026.

Stage 4: Clinical and screening deployment

The cleared or research-use device is placed in an eye clinic, memory clinic or research center for patient scanning, integrating into existing ophthalmology infrastructure rather than requiring new imaging equipment.

Stage 5: AI biomarker classification

A machine-learning classifier interprets the retinal scan to output a biomarker-positive/negative call or a quantitative risk score, the step where RetiSpec and Optina Diagnostics’ AI models operate.

Stage 6: Diagnostic pathway integration

The retinal-biomarker result feeds into the broader neurodegenerative-disease diagnostic and monitoring pathway alongside cognitive testing, blood-based biomarkers and, where available, PET imaging, offering a non-invasive and lower-cost screening layer ahead of more invasive confirmatory testing.