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Masked Ikervis
Masked Ikervis is a Calcineurin inhibitor (ophthalmic) Small molecule drug developed by Santen SAS. It is currently in Phase 3 development for Dry eye disease with significant inflammatory component.
Ikervis is a cyclosporine A ophthalmic emulsion that suppresses local immune-mediated inflammation in the ocular surface.
Ikervis is a cyclosporine A ophthalmic emulsion that suppresses local immune-mediated inflammation in the ocular surface. Used for Dry eye disease with significant inflammatory component.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Masked Ikervis |
|---|---|
| Sponsor | Santen SAS |
| Drug class | Calcineurin inhibitor (ophthalmic) |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Cyclosporine is a calcineurin inhibitor that reduces T-cell activation and pro-inflammatory cytokine production in the eye. By decreasing ocular surface inflammation, it addresses the underlying immune dysfunction in dry eye disease, particularly in cases with significant inflammatory component.
Approved indications
- Dry eye disease with significant inflammatory component
Common side effects
- Ocular irritation/burning
- Conjunctival hyperemia
- Foreign body sensation
- Blurred vision
Key clinical trials
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:
- Masked Ikervis CI brief — competitive landscape report
- Masked Ikervis updates RSS · CI watch RSS
- Santen SAS portfolio CI
Frequently asked questions about Masked Ikervis
What is Masked Ikervis?
How does Masked Ikervis work?
What is Masked Ikervis used for?
Who makes Masked Ikervis?
What drug class is Masked Ikervis in?
What development phase is Masked Ikervis in?
What are the side effects of Masked Ikervis?
What does Masked Ikervis target?
Related
- Drug class: All Calcineurin inhibitor (ophthalmic) drugs
- Target: All drugs targeting Calcineurin
- Manufacturer: Santen SAS — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease with significant inflammatory component
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing