Drug updated on 4/17/2024
| 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.
Summary
- 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 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 |