Cyclosporine ophthalmic emulsion

(Restasis®)

Restasis®

Drug updated on 11/4/2024

Dosage FormEmulsion (topical: 0.5 mg/mL)
Drug ClassCalcineurin inhibitor immunosuppressants
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Ocular Rosacea Treatments: Topical antimicrobials achieved a complete or partial response in 91% (n = 82/90) of patients, while oral antibiotics reached 89% (n = 525/580), and cyclosporine ophthalmic emulsion demonstrated an 87% response rate (n = 40/46). Combination treatments were also effective, yielding a response rate of 90% (n = 69/77).
  • Dry Eye Disease Treatments: Restasis (cyclosporine ophthalmic emulsion) showed the highest efficacy for reducing Ocular Surface Disease Index (OSDI) scores, with an odds ratio of 4.82 (95% CI 6.18 to 3.45). Zirun outperformed others in improving Schirmer's test scores (SUCRA (surface under the cumulative ranking curve) 73.9%), while TJ Cyporin was ranked highest for improving tear film break-up time (SUCRA 65.3%).
  • There is no safety information available in the reviewed studies for cyclosporine ophthalmic emulsion or other treatments for ocular rosacea. For dry eye disease, Clacier had the lowest incidence of treatment-emergent adverse events, comparable to placebo, while no specific safety outcomes were mentioned for Restasis.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Restasis (cyclosporine ophthalmic emulsion) Prescribing Information.2024AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Treatment of ocular rosacea: a systematic review2024Journal Der Deutschen Dermatologischen Gesellschaft = Journal Of The German
Comparison of seven cyclosporine A formulations for dry eye disease: A systematic review and network meta-analysis2022Frontiers In Pharmacology

Clinical Practice Guidelines

Document TitleYearSource
Perceptions of dry eye disease management in current clinical practice.2014Eye and Contact Lens