Tarsus Pharmaceuticals, Inc.

The company is a commercial-stage biopharmaceutical company focused on developing and commercializing therapeutics, primarily in eye care. In August 2023, the company launched XDEMVY® (lotilaner ophthalmic solution) 0.25%, previously known as TP-03, for treating Demodex blepharitis, following U.S. Food and Drug Administration (FDA) approval in July 2023. Demodex blepharitis is an eyelid inflammation caused by Demodex mite infestation, characterized by redness, ocular irritation, and eyelash dandruff called collarettes. This condition can lead to corneal damage and, in extreme cases, blindness. Approximately 25 million people in the U.S. may suffer from Demodex blepharitis. XDEMVY is the first and only FDA-approved therapeutic for this condition, targeting and eradicating Demodex mite infestation. Its active pharmaceutical ingredient, lotilaner, paralyzes and eradicates mites and other parasites by inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels, without inhibiting human GABA-Cl. The company has completed seven clinical trials for XDEMVY in Demodex blepharitis, including a Phase 3 trial (Saturn-2), a Phase 2b/3 trial (Saturn-1), four Phase 2 trials, and a Phase 1 trial (Hyperion), all of which met their primary, secondary, and/or certain exploratory endpoints. Additionally, clinical trials in Demodex blepharitis patients with Meibomian Gland Disease (MGD) have been completed, including a Phase 2a clinical trial (Ersa) and a pilot clinical trial (Rhea) involving an XDEMVY vehicle. The company plans to advance its pipeline using the lotilaner API to address various diseases in human medicine, including eye care and infectious disease prevention.