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Cyclosporine 0.05% ophthalmic solution
Cyclosporine 0.05% ophthalmic solution is a Calcineurin inhibitor Small molecule drug developed by Samsung Medical Center. It is currently FDA-approved for Dry eye disease (keratoconjunctivitis sicca).
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).
At a glance
| Generic name | Cyclosporine 0.05% ophthalmic solution |
|---|---|
| Sponsor | Samsung Medical Center |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
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, making it effective for dry eye disease where immune-mediated tear gland dysfunction is a key pathophysiology.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
Common side effects
- Ocular irritation or burning
- Conjunctival hyperemia
- 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
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cyclosporine 0.05% ophthalmic solution CI brief — competitive landscape report
- Cyclosporine 0.05% ophthalmic solution updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about Cyclosporine 0.05% ophthalmic solution
What is Cyclosporine 0.05% ophthalmic solution?
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Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin
- Manufacturer: Samsung Medical Center — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease (keratoconjunctivitis sicca)
- Compare: Cyclosporine 0.05% ophthalmic solution vs similar drugs
- Pricing: Cyclosporine 0.05% ophthalmic solution cost, discount & access