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CsA Ophthalmic Gel
CsA (cyclosporine A) ophthalmic gel suppresses T-cell activation and reduces inflammatory cytokine production in the eye to treat dry eye disease.
CsA (cyclosporine A) ophthalmic gel suppresses T-cell activation and reduces inflammatory cytokine production in the eye to treat dry eye disease. Used for Dry eye disease (moderate to severe).
At a glance
| Generic name | CsA Ophthalmic Gel |
|---|---|
| Also known as | CsA gel |
| Sponsor | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Cyclosporine A is a calcineurin inhibitor that blocks T-cell proliferation and the production of pro-inflammatory cytokines (IL-2, TNF-α, IFN-γ) implicated in dry eye pathogenesis. The ophthalmic gel formulation delivers the drug topically to the ocular surface, reducing inflammation and promoting tear production in patients with moderate-to-severe dry eye disease.
Approved indications
- Dry eye disease (moderate to severe)
Common side effects
- Ocular irritation/burning
- Conjunctival hyperemia
- Foreign body sensation
Key clinical trials
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients (PHASE3)
- Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users (PHASE3)
- Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease (PHASE3)
- Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease (PHASE4)
- Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye (PHASE2)
- Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) (PHASE2)
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:
- CsA Ophthalmic Gel CI brief — competitive landscape report
- CsA Ophthalmic Gel updates RSS · CI watch RSS
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. portfolio CI