Drug updated on 9/4/2024
Dosage Form | Emulsion (topical: 0.5 mg/mL) |
Drug Class | Calcineurin 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
- 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 Title | Year | Source |
---|---|---|
Restasis (cyclosporine ophthalmic emulsion) Prescribing Information. | 2017 | Allergan, Irvine, CA, U.S.A |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Comparison of seven cyclosporine A formulations for dry eye disease: A systematic review and network meta-analysis. | 2022 | Frontiers in Pharmacology |
Topical corticosteroids for dry eye. | 2022 | The Cochrane Database of Systematic Reviews |
Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: a systematic literature review. | 2019 | The Ocular Surface |
Topical cyclosporine A therapy for dry eye syndrome. | 2019 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Perceptions of dry eye disease management in current clinical practice. | 2014 | Eye and Contact Lens |