Tarsus Pharmaceuticals’ Xdemvy demonstrates positive efficacy and safety in treatment for patients with Demodex blepharitis.

1. Xdemvy is the first and only approved FDA treatment for Demodex blepharitis
2. Xdemvy can achieve collarette reduction of no more than 2 collarettes in 50% of patients after 6 weeks of treatment.

The Latest

Xdemvy’s SATURN-1 and SATURN-2 clinical trials have proven its efficacy and safety in treating Demodex blepharitis. In a phase 2b/3 clinical trial, patients were randomly assigned in a 1:1 ratio to receive either lotilaner (Xdemvy) or a vehicle without lotilaner bilaterally twice daily for 43 days. After 43 days, the lotilaner group achieved a statistically significant and favorable treatment in collarette cure, mite eradication, erythema cure, and composite cure compared to the control group. In SATURN-2 it was found that the lotilaner group achieved a collarette reduction to no more than 2 collarettes per upper eyelid in 56% of patients compared to 12.5 % of patients taking the vehicle by day 43.

Physician’s Perspective

Demodex blepharitis is a common disease of the eyelid, affecting approximately 25 million Americans. Researchers who have studied patient populations with clinical signs and symptoms of blepharitis found high rates of Demodex infestation with prevalence ranging from 29 to 90%. Demodex blepharitis can be confidently diagnosed by looking for collarettes during a routine slit lamp exam. The collarettes will be easily seen along the lash line of the upper eyelid margin when asking a patient to look down. During clinical trials, the efficacy of Xdemvy was found to have started working as early as 2 weeks with statistically significant improvements by day 43. The most common ocular adverse reactions associated with Xdemvy were site stinging and burning. Fewer than 2 percent of patients report styes or punctate keratitis associated with Xdemvy.

Molecular Target of Therapy

Blepharitis caused by Demodex mite infestation has several possible mechanisms including direct damage, acting as a vector for bacteria, and inducing hypersensitivity and inflammation reactions. Direct damage is through mite debris consisting of digestive enzymes and eggs which may cause direct surface irritation and inflammation. In acting as a vector for bacteria, Demodex mites carry concomitant bacteria such as Streptococcus and Staphylococcus species and will induce an immune response. Finally, Demodex infestation is associated with the upregulation of pro-inflammatory cytokines and other inflammatory cascades. Lotilaner, the active ingredient in Xdemvy is a GABA-gated chloride channel inhibitor selective for mites. Inhibitors of the chloride channels cause a paralytic state in the mites ultimately leading to their death.

Company History

Tarsus Pharmaceuticals is a California-based biopharmaceutical company focused on treating diseases with high unmet needs. The therapeutic categories Tarsus is currently focused on include eye care, dermatology, and infectious disease prevention. For skin care, Tarsus is focused on developing a topical formulation for the treatment of papulopustular rosacea. Tarsus’s infectious disease profile includes oral formulations for the treatment of Lyme disease and malaria.

Further reading: https://clinicaltrials.gov/study/NCT04475432

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