FDA approves Xdemvy to treat demodex blepharitis
Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that the FDA approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis
Xdemvy, formerly known as TP 03, is the first and only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis.
The FDA approval is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of Xdemvy in 833 patients, 415 of which received XDEMVY. Patients with Demodex blepharitis were randomized to either Xdemvy or vehicle at a 1:1 ratio and dosed twice daily in each eye over the course of 6 weeks.
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