Last reviewed · How we verify
Cyclosporine A eye drops 0.5%
Cyclosporine A eye drops 0.5% is a Calcineurin inhibitor Small molecule drug developed by Military Hospital of Tunis. It is currently FDA-approved for Dry eye disease (keratoconjunctivitis sicca), Ocular surface inflammation. Also known as: CsA.
Cyclosporine A suppresses T-cell activation and proliferation by inhibiting calcineurin, reducing inflammatory cytokine production in the eye.
Cyclosporine A suppresses T-cell activation and proliferation by inhibiting calcineurin, reducing inflammatory cytokine production in the eye. Used for Dry eye disease (keratoconjunctivitis sicca), Ocular surface inflammation.
At a glance
| Generic name | Cyclosporine A eye drops 0.5% |
|---|---|
| Also known as | CsA |
| Sponsor | Military Hospital of Tunis |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology / Immunology |
| Phase | FDA-approved |
Mechanism of action
Cyclosporine A is a calcineurin inhibitor that blocks the dephosphorylation of nuclear factor of activated T cells (NFAT), preventing T-cell activation and the production of pro-inflammatory cytokines such as IL-2. In the eye, this immunosuppressive action reduces inflammation associated with dry eye disease and other ocular surface inflammatory conditions. The 0.5% ophthalmic formulation delivers the drug topically to the ocular surface.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
- Ocular surface inflammation
Common side effects
- Ocular irritation / burning sensation
- Conjunctival hyperemia
- Foreign body sensation
- Transient blurred vision
Key clinical trials
- Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax (PHASE4)
- Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients (PHASE4)
- Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial (PHASE1)
- Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease (PHASE4)
- Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis (PHASE4)
- Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) (PHASE2)
- A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis® (PHASE4)
- A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
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 A eye drops 0.5% CI brief — competitive landscape report
- Cyclosporine A eye drops 0.5% updates RSS · CI watch RSS
- Military Hospital of Tunis portfolio CI
Frequently asked questions about Cyclosporine A eye drops 0.5%
What is Cyclosporine A eye drops 0.5%?
How does Cyclosporine A eye drops 0.5% work?
What is Cyclosporine A eye drops 0.5% used for?
Who makes Cyclosporine A eye drops 0.5%?
Is Cyclosporine A eye drops 0.5% also known as anything else?
What drug class is Cyclosporine A eye drops 0.5% in?
What development phase is Cyclosporine A eye drops 0.5% in?
What are the side effects of Cyclosporine A eye drops 0.5%?
What does Cyclosporine A eye drops 0.5% target?
Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (protein phosphatase 2B)
- Manufacturer: Military Hospital of Tunis — full pipeline
- Therapeutic area: All drugs in Ophthalmology / Immunology
- Indication: Drugs for Dry eye disease (keratoconjunctivitis sicca)
- Indication: Drugs for Ocular surface inflammation
- Also known as: CsA
- Compare: Cyclosporine A eye drops 0.5% vs similar drugs
- Pricing: Cyclosporine A eye drops 0.5% cost, discount & access