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Rebamipide 2% ophthalmic solution
Rebamipide promotes ocular surface healing and reduces inflammation by stimulating mucin secretion and protecting epithelial cells.
Rebamipide promotes ocular surface healing and reduces inflammation by stimulating mucin secretion and protecting epithelial cells. Used for Dry eye disease, Ocular surface disorder.
At a glance
| Generic name | Rebamipide 2% ophthalmic solution |
|---|---|
| Sponsor | Samsung Medical Center |
| Drug class | Mucoprotective agent |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Rebamipide is a mucoprotective agent that enhances the production of mucin by goblet cells in the conjunctiva, thereby improving tear film stability and ocular surface protection. It also exhibits anti-inflammatory properties by reducing cytokine production and protecting corneal and conjunctival epithelial cells from damage. These mechanisms make it effective for treating dry eye disease and other ocular surface disorders.
Approved indications
- Dry eye disease
- Ocular surface disorder
Common side effects
- Eye irritation
- Conjunctival hyperemia
- Blurred vision
Key clinical trials
- Rebamipide Versus Diquafosol for Perioperative Dry Eye in Cataract Surgery (PHASE4)
- Rebamipide Versus Diquafosol and Cyclosporine for Perioperative Dry Eye in Cataract Surgery (PHASE4)
- Safety Study of OPC-12759 Ophthalmic Solution (PHASE1)
- Exploratory Study of OPC-12759 Ophthalmic Suspension (PHASE2)
- Confirmatory Study of OPC-12759 Ophthalmic Suspension (PHASE3)
- Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea (PHASE2)
- Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye (PHASE2)
- Study of Rebamipide Eye Drops to Treat Dry Eye (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:
- Rebamipide 2% ophthalmic solution CI brief — competitive landscape report
- Rebamipide 2% ophthalmic solution updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI