Drug updated on 12/11/2024
Dosage Form | Ophtalmic solution (topical; 2.5 mg/mL [0.25%]) |
Drug Class | Ectoparasiticides |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Demodex blepharitis.
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Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Lotilaner showed significant effectiveness in treating Demodex blepharitis, with an odds ratio (OR) of 6.64 (95% confidence interval (CI), 3.78 to 11.04; p < 0.00001) for collarette cure, and a reduction in mite density with an OR of 9.37 (95% CI, 5.36 to 16.36; p < 0.00001).
- Lotilaner significantly reduced mite eradication rates (OR 6.18; 95% CI, 4.67 to 6.18; p < 0.00001) and demonstrated improvements in erythema cure (OR 2.29; 95% CI, 2.24 to 3.39; p < 0.00001), as well as composite cure (OR 7.05; 95% CI, 3.66 to 13.61; p < 0.00001).
- Across various studies, lotilaner was well-tolerated, with better safety and effectiveness compared to other treatments such as tea tree oil and antibiotics, showing no significant adverse effects.
- Lotilaner was well-tolerated with no significant adverse events reported compared to the vehicle. There was no significant difference in adverse events between the treatment and control groups (RR 1.25, 95% CI [0.75 to 2.06]).
- While high heterogeneity in some safety outcomes was reported, there were no immediate concerns or significant long-term safety issues identified in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xdemvy (lotilaner) Prescribing Information. | 2023 | Tarsus Pharmaceuticals Inc., Irvine, CA |