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INS365 Ophthalmic Solution
INS365 is a small-molecule selective inhibitor of inositol 1,4,5-trisphosphate (IP3) receptors that reduces intracellular calcium signaling in ocular surface cells.
INS365 is a small-molecule selective inhibitor of inositol 1,4,5-trisphosphate (IP3) receptors that reduces intracellular calcium signaling in ocular surface cells. Used for Dry eye disease (keratoconjunctivitis sicca).
At a glance
| Generic name | INS365 Ophthalmic Solution |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | IP3 receptor antagonist |
| Target | IP3 receptor (inositol 1,4,5-trisphosphate receptor) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
By blocking IP3 receptor-mediated calcium release, INS365 decreases mucin secretion and inflammatory mediator release from conjunctival goblet cells and other ocular surface tissues. This mechanism addresses the underlying pathophysiology of dry eye disease by reducing both aqueous tear deficiency and mucin dysfunction.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca)
Common side effects
- Instillation site discomfort
- Blurred vision
- Eye irritation
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)
- 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis (PHASE3)
- Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery
- Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK (NA)
- Diquafosol vs Hyaluronic Acid for Diabetic Dry Eye (NA)
- Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients (PHASE3)
- Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK (NA)
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:
- INS365 Ophthalmic Solution CI brief — competitive landscape report
- INS365 Ophthalmic Solution updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI