LIAN - Tarsus granted FDA nod for lead asset
2023-07-26 08:50:00 ET
Tarsus Pharmaceuticals ( NASDAQ: TARS ) announced Tuesday that the FDA greenlighted its lead asset TP-03 as a treatment for the eyelid disorder Demodex blepharitis.
Demodex blepharitis affects approximately 25M eyecare patients in the U.S., with a prevalence of 1 out of every 12 adults.
The treatment, branded as Xdemvy, is the first and only FDA-approved treatment directly targeted at Demodex mites, the causative agent of Demodex blepharitis, Tarsus ( TARS ) said.
The FDA’s decision is backed by data from two randomized trials in which Xdemvy outperformed a comparative agent in terms of eyelid improvement over six weeks. The eyecare solution was also found to be safe and well tolerated in the trials. The company expects to launch Xdemvy as a prescription medicine by the end of August.
Despite the approval, Tarsus ( TARS ) shares fell for the second straight session Tuesday following insider sales by the company’s chief executive, Bobak Azamian, and chief commercial officer, Aziz Mottiwala, last week as part of two previously adopted trading plans.
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Tarsus granted FDA nod for lead asset