The evidence-based indications of 0.1% topical tacrolimus in ophthalmology: a scoping review.

OBJECTIVE

To summarize evidence-based indications of topical 0.1% tacrolimus in treating ophthalmological diseases.

METHODS

A comprehensive literature review was conducted using PubMed, Embase, and Wanfang databases. Two independent reviewers screened studies according to predefined criteria: original human research (case reports/series, prospective/retrospective studies, RCTs) on ophthalmic applications of 0.1% tacrolimus were included, while reviews, conference abstracts, non-ophthalmic studies, alternative formulations/routes, and preclinical studies were excluded. Two reviewers independently extracted data using a piloted form, resolving discrepancies through thorough discussion. Extracted variables included study details (author, year, design, location), population characteristics (patients/eyes), and intervention protocols. Data were synthesized thematically by ocular disease category, with comparative analysis of study designs, treatment regimens, and clinical outcomes.

RESULTS

0.1% topical tacrolimus significantly improves the signs and symptoms of a wide spectrum of inflammatory eye conditions of the anterior segment, namely allergic conjunctivitis, viral conjunctivitis, immune checkpoint inhibitor-related conjunctivitis, ocular cicatricial pemphigoid, nodular episcleritis, graft rejection, graft-versus-host diseases, dry eye disease, autoimmune keratitis, blepharitis, and periorbital dermatitis. In addition to monotherapy, 0.1% tacrolimus can be used as an adjunct alongside other medications such as topical steroids and topical cyclosporine. The medication is generally well-tolerated with minimal side effects, with the most common complaint being local stinging, which dampens over time. Its reassuring safety profile in the ocular application is evidenced by its minimal systemic absorption post-administration.

CONCLUSION

0.1% tacrolimus is effective and safe for a wide spectrum of eye diseases involving the anterior segment and adnexa. Not only does 0.1% topical tacrolimus spare patients from the side effects of chronic topical corticosteroid use but it also emerges as an option for patients inadequately managed by other immunosuppressants, highlighting the growing significance of 0.1% tacrolimus in ophthalmic practice.