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Lotilaner ophthalmic solution, 0.25%
Lotilaner is a non-selective sigma receptor antagonist that reduces ocular surface inflammation and irritation associated with Demodex mites.
Lotilaner is a non-selective sigma receptor antagonist that reduces ocular surface inflammation and irritation associated with Demodex mites. Used for Demodex blepharitis, Ocular rosacea.
At a glance
| Generic name | Lotilaner ophthalmic solution, 0.25% |
|---|---|
| Sponsor | Tarsus Pharmaceuticals, Inc. |
| Drug class | Sigma receptor antagonist |
| Target | Sigma receptors (non-selective) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Lotilaner works by antagonizing sigma receptors, which are involved in inflammatory pathways on the ocular surface. By blocking these receptors, it reduces the inflammatory response triggered by Demodex mites and their byproducts, thereby alleviating symptoms of ocular rosacea and blepharitis. The drug is formulated as a topical ophthalmic solution for direct application to the eye.
Approved indications
- Demodex blepharitis
- Ocular rosacea
Common side effects
- Instillation site irritation
- Conjunctival hyperemia
- Eye discomfort
- Blurred vision
Key clinical trials
- Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD (PHASE2)
- Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers (PHASE4)
- A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects (PHASE1)
- Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex (PHASE2)
- Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (PHASE2, PHASE3)
- Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (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 |
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