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Cyclosporine ophthalmic solution, 0.1%
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 ophthalmic solution, 0.1% |
|---|---|
| Also known as | VEVYE |
| Sponsor | Novaliq GmbH |
| 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 associated with dry eye disease by decreasing T-cell infiltration and pro-inflammatory cytokine release in the lacrimal gland and ocular surface.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
Common side effects
- Ocular irritation/burning
- Conjunctival erythema
- Blurred vision
- Foreign body sensation
Key clinical trials
- Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (PHASE4)
- A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study (PHASE4)
- Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT (NA)
- Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears
- A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment (PHASE4)
- Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A (PHASE3)
- 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis (PHASE3)
- Cord Blood Platelet Poor Plasma Eye Drops (NA)
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 ophthalmic solution, 0.1% CI brief — competitive landscape report
- Cyclosporine ophthalmic solution, 0.1% updates RSS · CI watch RSS
- Novaliq GmbH portfolio CI