Drug updated on 4/16/2024
| 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.
Summary
- Lotilaner (Xdemvy) is indicated for the treatment of Demodex blepharitis, showing significant improvements in key clinical indicators such as reductions in mite density, eradication within six weeks, reduction in collarettes, and erythema cure.
- Two systematic reviews/meta-analyses were analyzed to gather information about Xdemvy's effectiveness and safety profile.
- The studies included adults as participants but did not detail specific subgroup considerations; future research could benefit from stratifying results by these variables to determine if certain subgroups respond more favorably or if specific risks are associated with particular patient segments.
- In terms of safety, both studies highlighted that lotilaner's safety profile was comparable to the control group with no significant increase in adverse events reported.
- While direct comparisons to other treatments were not available in the studies provided, lotilaner showed substantial statistical benefits over placebo/vehicle groups, which suggests its potential superiority or at least viability as a safe and effective treatment option for Demodex blepharitis.
- Both studies mention limitations regarding the heterogeneity of outcomes and recommend larger study populations for future research, along with direct comparisons with other treatments for Demodex blepharitis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xdemvy (lotilaner) Prescribing Information. | 2023 | Tarsus Pharmaceuticals Inc., Irvine, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of Lotilaner ophthalmic solution 0.25% in the treatment of Demodex Blepharitis: a systematic review and meta-analysis. | 2024 | Ocular Immunology and Inflammation |
| A systematic review and meta-Analysis of the safety and efficacy of 0.25% Lotilaner ophthalmic solution in the treatment of Demodex Blepharitis. | 2024 | Cureus |