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Open-label Ikervis
Ikervis is a lipid emulsion eye drop that reduces inflammation and promotes tear production in dry eye disease by delivering cyclosporine to the ocular surface.
Ikervis is a lipid emulsion eye drop that reduces inflammation and promotes tear production in dry eye disease by delivering cyclosporine to the ocular surface. Used for Severe keratoconjunctivitis sicca (dry eye disease) in adults.
At a glance
| Generic name | Open-label Ikervis |
|---|---|
| Sponsor | Santen SAS |
| Drug class | Immunosuppressant (topical ophthalmic) |
| Target | Calcineurin (via cyclosporine binding to cyclophilin) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Ikervis (cyclosporine 0.05% in cationic emulsion) is an immunosuppressant that inhibits T-cell activation and reduces inflammatory cytokine production in the lacrimal gland and ocular surface. The cationic emulsion formulation enhances corneal penetration and retention, allowing cyclosporine to reach deeper ocular tissues and restore tear production in patients with keratoconjunctivitis sicca (dry eye disease).
Approved indications
- Severe keratoconjunctivitis sicca (dry eye disease) in adults
Common side effects
- Eye irritation/discomfort
- Conjunctival hyperemia
- Visual disturbance/blurred vision
- Eye pain
- Lacrimation
Key clinical trials
- 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) (PHASE3)
- Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis (PHASE4)
- Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment (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:
- Open-label Ikervis CI brief — competitive landscape report
- Open-label Ikervis updates RSS · CI watch RSS
- Santen SAS portfolio CI