Methods for treating ocular demodex using isoxazoline parasiticide formulations

Inventors

Azamian, Bobak Robert • Ackermann, Douglas Michael • Hickok, Shawn D. • Vehige, Joseph G.

Assignees

Tarsus Pharmaceuticals Inc

Abstract

Disclosed herein are methods for treating or preventing ophthalmic and dermatologic conditions in a patient, including ocular surface conditions such as blepharitis. The methods can include topically administering directly to an ocular surface of one or more eyes of a patient in need of treatment thereof an effective amount of an isoxazoline parasiticide, formamidine parasiticide, or other active ingredient, formulated into an ophthalmic composition, the ophthalmic composition further comprising a pharmaceutically acceptable vehicle. Compositions are also disclosed.

Core Innovation

The disclosed invention relates to treating Demodex blepharitis by topically administering directly to an ocular surface of one or more eyes of a human patient an effective amount of an isoxazoline parasiticide. The isoxazoline parasiticide is formulated into an ophthalmic composition that comprises a pharmaceutically acceptable vehicle and is provided as an eye drop. The ophthalmic composition is sterile and non-irritating to the eye, does not comprise tea tree oil, and the isoxazoline parasiticide is the sole active ingredient, with the isoxazoline parasiticide comprising lotilaner or fluralaner.

A further aspect is the treatment of Demodex blepharitis by topically administering an isoxazoline parasiticide to one or more of the eye, eyelids, or eyelashes of the human patient. In this approach, the ophthalmic composition is sterile and non-irritating to the eye, comprises an eye drop, does not comprise tea tree oil, and includes the isoxazoline parasiticide as the sole active ingredient, where the isoxazoline parasiticide comprises lotilaner or fluralaner. Additional refinements include keeping the patient’s eyes closed to contact the orifices of Meibomian glands and the area outside eyelid margins, and spreading the composition onto the eyelashes and the eyelashes’ follicles using an applicator.

Another aspect is treating an ocular Demodex infestation by topically administering directly to an ocular surface of one or more eyes of a human patient an effective amount of an isoxazoline parasiticide formulated into an ophthalmic composition with a pharmaceutically acceptable vehicle. The ophthalmic composition is sterile and non-irritating to the eye, comprises an eye drop, does not comprise tea tree oil, and has the isoxazoline parasiticide as the sole active ingredient, comprising lotilaner or fluralaner. The disclosures further include embodiments where the infestation includes blepharitis, ocular rosacea, and/or Meibomian gland dysfunction, and administration occurs when the quantity of Demodex mites is greater than a predetermined value.

Claims Coverage

The partial content provides three independent methods covering treatment of Demodex blepharitis or ocular Demodex infestation using a sterile, non-irritating isoxazoline parasiticide eye-drop composition that excludes tea tree oil and uses the isoxazoline as the sole active ingredient.

Across the independent claims, the core coverage is the use of an eye-drop ophthalmic composition that is sterile and non-irritating, excludes tea tree oil, contains an isoxazoline parasiticide as the sole active ingredient, and directs treatment topically to ocular surfaces or to the eye, eyelids, or eyelashes for Demodex blepharitis or ocular Demodex infestation, with the isoxazoline parasiticide comprising lotilaner or fluralaner.

Stated Advantages

Documented Applications