Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis

• Published in: Healthcare (Basel) Vol. 12; no. 15; p. 1487
• Main Authors: Davey, Pinakin Gunvant, Farid, Marjan, Karpecki, Paul, Gaddie, Ian Benjamin, Chan, Arthur, Mun, James, Neervannan, Sesha, Yeu, Elizabeth
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.08.2024
• Subjects: blepharitis; Clinical trials; Demodex; dry eye; Erythema; Eye diseases; Eyelids; FDA approval; Health aspects; Inflammation; lotilaner; Mites; Pharmacists; United States; United States > US; Mexico
• ISSN: 2227-9032; 2227-9032
• DOI: 10.3390/healthcare12151487

Demodex blepharitis, a chronic lid margin disease, is caused by an infestation of Demodex mites, the most common ectoparasites in human skin and eyelids. Lotilaner ophthalmic solution, 0.25% (Xdemvy, Tarsus Pharmaceuticals), is the first therapy approved to treat Demodex blepharitis. This narrative review characterizes lotilaner ophthalmic solution, 0.25%, and describes its efficacy, safety, and tolerability. The safety and efficacy of lotilaner ophthalmic solution, 0.25%, for treating Demodex blepharitis was evaluated in four phase 2 and two phase 3 trials. The data of 980 patients included in these phase 2 and 3 clinical trials revealed that the proportion of eyes with a clinically meaningful reduction to 10 or fewer collarettes (the cylindrical, waxy debris found at the base of the eyelashes) ranged from 81 to 93%. The mite eradication rate confirmed by a microscopy of epilated lashes ranged from 52 to 78%. No serious treatment-related adverse events were reported in any of these clinical studies. As high as 92% of the patients receiving lotilaner eyedrops in the phase 3 trials found it to be neutral to very comfortable. Given the positive safety and efficacy outcomes, the drug is likely to become the standard of care in the treatment of Demodex blepharitis.