Recent Developments in Tear Fluid Biomarkers: An Expert Perspective on Clinical Translation

Tear fluid biomarker research is rapidly growing in both ocular and non-ocular diseases, with biomarker-based tests gradually transitioning into clinical applications. As this progress continues, translation into routine practice remains limited. This perspective aims to summarize key advances with direct clinical relevance and identify the major barriers that must be overcome for widespread adoption.

This perspective is based on the authors' multidisciplinary expertise combined with a focused review of the current literature on tear fluid biomarkers and point-of-care applications.

Several substances identified in tear fluid have been considered as potential biomarkers. As a result, specific point-of-care tests have reached the market, with several more close to clinical development. While these tests offer objective and quantifiable values, significant challenges persist, including suboptimal sensitivity and specificity, lack of standardized collection and analysis protocols, absence of validated reference ranges and diagnostic thresholds, regulatory and reimbursement barriers, and limited clinical awareness. Importantly, most current applications remain focused on diagnosis, while unmet clinical needs such as prognostication, therapy guidance, and longitudinal monitoring remain underexplored.

To achieve meaningful clinical integration, research must progress from discovery to standardization, validation, and alignment with real-world needs. Addressing these challenges is essential to incorporate the analysis of tear fluid biomarkers into routine care and advance precision diagnostics and personalized therapy in ophthalmology and related fields.