Lotilaner

(Xdemvy®)

Xdemvy®

Drug updated on 11/5/2024

Dosage FormOphtalmic solution (topical; 2.5 mg/mL [0.25%])
Drug ClassEctoparasiticides
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Demodex blepharitis.

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Summary
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  • 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% 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, as noted in Document 3. In Document 4, 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 in Document 1, 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.