Tarsus Pharmaceuticals Receives the US FDA’s Approval of Xdemvy (lotilaner ophthalmic solution) for the Treatment of Demodex Blepharitis
Shots:
- The US FDA has approved Xdemvy, the first and only US FDA-approved treatment to directly target Demodex mites for the treatment of Demodex blepharitis. Xdemvy is expected to be available by prescription at the end of Aug 2023
- The approval was based on two studies (Saturn-1 & 2) evaluating Xdemvy vs vehicle in a ratio (1:1) in 833 patients which showed an improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than 2 collarettes per upper lid) in each study by Day 43 with some patients showed improvement as early as 2wks.
- The EPs of mite eradication & erythema cure showed an improvement at Day 43 across both studies, and were safe & well tolerated while other ocular adverse reactions were reported in ≤2% of patients
Ref: Tarsus Pharmaceuticals | Image: Tarsus Pharmaceuticals
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