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Cyclosporine 0.09% Ophthalmic Solution
Cyclosporine 0.09% Ophthalmic Solution is a Calcineurin inhibitor Small molecule drug developed by Center for Ophthalmic and Vision Research, LLC. It is currently FDA-approved for Dry eye disease (keratoconjunctivitis sicca). Also known as: Cequa Ophthalmic Product.
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 0.09% Ophthalmic Solution |
|---|---|
| Also known as | Cequa Ophthalmic Product |
| Sponsor | Center for Ophthalmic and Vision Research, LLC |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Cyclosporine inhibits calcineurin, a phosphatase required for T-cell receptor signaling 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. The 0.09% ophthalmic formulation delivers the drug topically to achieve local immunosuppression while minimizing systemic exposure.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
Common side effects
- Ocular irritation/burning
- Conjunctival erythema
- Foreign body sensation
- Blurred vision
- Ocular discharge
Key clinical trials
- Improving Drop Instillation Comfort of a Cyclosporine A Solution (NA)
- CEQUA for Sjogren's Syndrome Dry Eye (PHASE4)
- Effect of Cequa™ in Subjects With Dry Eye Disease (PHASE4)
- Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days (PHASE4)
- Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (PHASE3)
- Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery (PHASE4)
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 0.09% Ophthalmic Solution CI brief — competitive landscape report
- Cyclosporine 0.09% Ophthalmic Solution updates RSS · CI watch RSS
- Center for Ophthalmic and Vision Research, LLC portfolio CI
Frequently asked questions about Cyclosporine 0.09% Ophthalmic Solution
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Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (protein phosphatase 2B)
- Manufacturer: Center for Ophthalmic and Vision Research, LLC — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease (keratoconjunctivitis sicca)
- Also known as: Cequa Ophthalmic Product
- Compare: Cyclosporine 0.09% Ophthalmic Solution vs similar drugs
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