ArticleClinical ophthalmology (Auckland, N.Z.)2026
Tear Biomarkers of Topical Sirolimus in Meibomian Gland Dysfunction: A Randomized Trial.
Article in Clinical ophthalmology (Auckland, N.Z.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Purpose: Pharmacodynamic biomarkers of sirolimus were investigated using omics analysis of tear fluids from Japanese patients with meibomian gland dysfunction (MGD). Methods: In a Phase 2a trial, sirolimus or vehicle eyedrops were administered twice daily for 12 weeks. Tear samples from 29 patients (15 sirolimus, 14 vehicle) were collected pre- and post-treatment. LC-MS/MS-based proteomics and lipidomics were performed. Within-group changes were analyzed, followed by differential expression and pathway analysis. Key candidates were evaluated using estimation plots (Registration ID: UMIN000049186). Results: Over 3000 proteins and 55 lipids were quantified. mTOR signaling components (ATP6V1D, RRAGC, DEPTOR) were significantly modulated. ATP6V1D showed a significant decrease in the sirolimus group (p = 0.0024), but not in the vehicle group (p = 0.528). Lipids 12-HETE and 13-HpODE significantly increased post-treatment in the sirolimus group. Conclusion: Results suggested that sirolimus inhibited the mTOR pathway. ATP6V1D, 12-HETE, and 13-HpODE were suggested to be pharmacodynamic biomarkers for sirolimus. These findings may facilitate pharmacodynamic monitoring of mTOR-targeted therapies for ocular surface disorders.
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