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Cyclosporine ophthalmic solution 0.05%
Cyclosporine is a calcineurin inhibitor that suppresses T-cell activation and reduces inflammatory cytokine production in the eye.
Cyclosporine is a calcineurin inhibitor that suppresses T-cell activation and reduces inflammatory cytokine production in the eye. Used for Dry eye disease (keratoconjunctivitis sicca), Ocular inflammation associated with dry eye.
At a glance
| Generic name | Cyclosporine ophthalmic solution 0.05% |
|---|---|
| Sponsor | Taejoon Pharmaceutical Co., Ltd. |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Cyclosporine binds to cyclophilin and inhibits calcineurin, a phosphatase required for T-cell activation and IL-2 production. In the eye, this immunosuppressive effect reduces inflammation and increases tear production, particularly beneficial in dry eye disease where autoimmune mechanisms contribute to lacrimal gland dysfunction and ocular surface inflammation.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
- Ocular inflammation associated with dry eye
Common side effects
- Ocular irritation/burning
- Conjunctival hyperemia
- Transient blurred vision
- Foreign body sensation
Key clinical trials
- Rebamipide Versus Diquafosol and Cyclosporine for Perioperative Dry Eye in Cataract Surgery (PHASE4)
- Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT (NA)
- Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom (NA)
- A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease (PHASE2)
- Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease (PHASE4)
- The Effect of 0.05% CsA Eye Drops on Diabetic Patients with Dry Eye Disease (PHASE4)
- Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device (PHASE1, PHASE2)
- Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024 (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |