Validated Biomarkers Lacking for Ocular Allergy, Dry Eye Disease

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Clinicians have resources available to them to assist in identifying ocular surface biomarkers, but a need exists for a universal standard.

Fully validated biomarkers used to identify and manage ocular allergy (OA) and dry eye disease (DED) are severely lacking, according to a review published in Experimental Eye Research. Researchers have initiated the process of identifying several legitimate biomarkers, but many must still undergo the full validation process. 

Researchers obtained data from 171 articles after conducting a PubMed search. They entered the terms “tears,” “ocular surface” and “biomarkers,” and screened titles and abstracts for articles discussing biomarker expression and correlation. The team included articles published within the last 20 years. 

Investigators compiled a review based on their findings to identify relevant biomarkers of OA and DED. They determined that obtaining tears and epithelial tissue samples were the least invasive means of collecting this data. The team noted an association between inflammation and interleukin proteins (IL-1α, IL-1β and IL-17), tumour necrotic factor (TNFα) and interferon gamma (IFNγ; 38 Th1-Th7 pathway) and IL-4, IL-5 and IL-13 (Th2 pathway). They also determined that a change in mucin level (MUC1, MUC2, MUC4, MUC5 and MUC16) correlates with tear film mucous layer alterations.

The publication provides resources and databases clinicians can access to stay abreast of the most current biomarkers. Among these are the Food and Drug Administration’s (FDA) Biomarkers EndpointS and other Tools (BEST), Human Eye Proteome Project (HEPP) reports, and the Tear Film and Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II). These sources identify various biomarkers including lipids, proteins, metabolites, and electrolytes that assist in the diagnosis of DED and OA. 

Despite the accessibility of these resources, researchers acknowledge a need for a cohesive, evidence-based standard for identifying ocular surface biomarkers. 

“There is an urgent need for global unification of clinical classification and diagnostics criteria. Widespread integration of proteomic and transcriptomic data is paramount for performing meaningful analyses using appropriate bioinformatics tools and artificial intelligence systems,” investigators report.


Suárez-Cortés T, Merino-Inda N, Benitez-del-Castillo JM. Tears and ocular surface disease biomarkers: a diagnostic and clinical perspective for ocular allergy and dry eye disease. Exp Eye Res. Published online May 20, 2022. doi:10.1016/j.exer.2022.109121