Cyclosporine ophthalmic emulsion

(Restasis®)

Cyclosporine ophthalmic emulsion

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Drug updated on 4/17/2024

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.

Summary
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  • Cyclosporine ophthalmic emulsion (Restasis) is indicated to increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
  • Three systematic reviews/meta-analyses evaluated different aspects of dry eye treatment, conducting a comparative analysis against other treatments for dry eye disease (DED), with an emphasis on safety and effectiveness.
  • Restasis showed the most effectiveness in reducing the Ocular Surface Disease Index (OSDI) compared to other commercial formulations of cyclosporine A for DED. However, Zirun and TJ Cyporin demonstrated better performances in improving Schirmer's test scores and tear film break-up time, respectively.
  • Compared to topical corticosteroids used for treating DED, Restasis exhibits a favorable safety profile, as corticosteroids may increase the risk of intraocular pressure elevation and cataract formation.
  • In terms of efficacy among various ophthalmic drugs for DED, including cyclosporine A, no large study demonstrated statistical significance; however, lifitegrast did show superiority over control groups in symptom or sign endpoint during large multicenter trials.
  • The studies do not provide detailed information on population types or subgroup considerations, but it was noted that all except one trial recruited adults, with a significant number being female, suggesting broader applicability across adult populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Restasis (cyclosporine ophthalmic emulsion) Prescribing Information.2017Allergan, Irvine, CA, U.S.A

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

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