Cyclosporine ophthalmic emulsion

(Restasis®)

Restasis®

Drug updated on 9/4/2024

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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  • Restasis (cyclosporine ophthalmic emulsion) is indicated to increase tear production in patients with presumed suppression of tear production due to ocular inflammation associated with keratoconjunctivitis sicca.
  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Restasis (Cyclosporine A 0.05%): Demonstrated the highest effectiveness in reducing the Ocular Surface Disease Index (OSDI) (OR = 4.82, 95% CI = 6.18 to 3.45, SUCRA 77.2%), but was not the top-performing drug for Tear Film Break-Up Time (TBUT), where TJ Cyporin ranked first (SUCRA 65.3%).
  • Comparative Effectiveness: Zirun showed superior performance in improving Schirmer's test (SUCRA 73.9%), while topical steroids demonstrated a small to moderate improvement in patient-reported symptoms (SMD 0.29, 95% CI 0.16 to 0.42) and corneal staining scores (SMD 0.4, 95% CI 0.18 to 0.62) compared to lubricants, with varying effectiveness when compared to CsA.
  • Population Considerations: Trials predominantly involved adult female participants (median 79%), with one trial including children aged 3 to 14 years, covering a range of dry eye severities and etiologies.
  • Restasis (Cyclosporine A 0.05%) was associated with a higher likelihood of treatment-related adverse events, particularly burning and stinging, compared to the vehicle (RR = 1.33, 95% CI = 1.00 to 1.78).
  • Topical steroids showed an increased risk of intraocular pressure (IOP) elevation compared with lubricants (RR = 5.96, 95% CI = 1.30 to 27.38), with potential risks of ocular hypertension and infections with long-term use. The risk of cataract formation remained uncertain due to short-term study durations.

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