Background
There is a need to translate evidence from randomised controlled trials (RCTs) into recommendations for prescribing topical ciclosporin A (CsA) in ocular surface disease (OSD), to inform clinicians and support improvements in Australian eyecare and research.
Methods
A systematic review with meta-analysis, review of the Therapeutic Goods Administration approvals, Pharmaceutical Benefit Scheme (Australia) and evaluation of the quality of available evidence with expert-led consensus was used to develop practical recommendations for the use of topical CsA for OSD.
Results
Most RCTs of topical CsA for OSD were available for aqueous-deficient dry eye disease (DED). In the RCTs, prior to prescribing topical CsA, patients were assessed for symptoms (e.g., Ocular Surface Disease Index) and signs (e.g., tear secretion, corneal fluorescein staining). In Australia, topical CsA was available as Ikervis® (CsA 0.1 % cationic nanoemulsion), Cequa® (CsA 0.09 % nanomicellar solution), Restasis® (CsA 0.05 % oil-in-water emulsion) and compounded products (CsA 0.02 %, 0.05 %, 0.2 %, 0.5 %, 1.0 %). Recommendations for prescribing topical CsA included that it could be considered when DED symptoms and/or signs were not adequately controlled by preservative-free artificial tear monotherapy. Timeline for an improvement with CsA treatment was noted as within 4 to 12 weeks, to inform follow-up schedules. Potential ocular side effects associated with topical CsA included stinging and irritation on instillation. Evidence was limited for topical CsA use in individuals <18 years and it was not recommended for patients planning a pregnancy, or who are pregnant or lactating.
Conclusion
Topical CsA may be used to treat OSD, with most evidence supporting its efficacy for aqueous-deficient DED. Treatment in adults, aside from pregnant or lactating patients or those planning pregnancy, was generally safe with no serious adverse events reported.
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