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NOVA22007 ''Ciclosporin''
Ciclosporin suppresses T-cell activation and proliferation by inhibiting calcineurin, thereby reducing inflammatory immune responses.
Ciclosporin suppresses T-cell activation and proliferation by inhibiting calcineurin, thereby reducing inflammatory immune responses. Used for Dry eye disease (keratoconjunctivitis sicca), Uveitis, Other immune-mediated ocular inflammatory conditions.
At a glance
| Generic name | NOVA22007 ''Ciclosporin'' |
|---|---|
| Sponsor | Santen SAS |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Ciclosporin binds to cyclophilin and inhibits the phosphatase calcineurin, preventing dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of pro-inflammatory cytokines such as IL-2, TNF-α, and IFN-γ, leading to broad immunosuppression. It is used in conditions where immune-mediated inflammation drives pathology.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
- Uveitis
- Other immune-mediated ocular inflammatory conditions
Common side effects
- Ocular irritation or burning
- Conjunctival hyperemia
- Headache
- Systemic immunosuppression (with systemic use)
Key clinical trials
- 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) (PHASE3)
- Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis (PHASE3)
- Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC) (PHASE2, PHASE3)
- NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye (PHASE2)
- Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome (PHASE3)
- Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis (PHASE3)
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:
- NOVA22007 ''Ciclosporin'' CI brief — competitive landscape report
- NOVA22007 ''Ciclosporin'' updates RSS · CI watch RSS
- Santen SAS portfolio CI