Tarsus Pharmaceuticals, Inc. announced that XDEMVY? (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis.

XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks.

Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease ? Demodex mite infestation.

The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients.

Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients.

Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.