Claims for Patent: 10,835,517

Summary for Patent: 10,835,517

Title:	Methods for treating ocular demodex using isoxazoline parasiticide formulations
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.
Inventor(s):	Bobak Robert Azamian, Douglas Michael Ackermann, Shawn D. Hickok, Joseph G. Vehige
Assignee:	Tarsus Pharmaceuticals Inc
Application Number:	US16/221,390
Patent Claims:	1. A method for treating Demodex blepharitis, comprising: topically administering directly to an ocular surface of one or more eyes of a human patient in need of treatment thereof an effective amount of an isoxazoline parasiticide, formulated into an ophthalmic composition, the ophthalmic composition further comprising a pharmaceutically acceptable vehicle, wherein the ophthalmic composition is sterile and non-irritating to the eye, wherein the ophthalmic composition comprises an eye drop, wherein the ophthalmic composition does not comprise tea tree oil, wherein the isoxazoline parasiticide is the sole active ingredient of the ophthalmic composition, wherein the ophthalmic composition is only locally therapeutically effective, and wherein the isoxazoline parasiticide comprises lotilaner or fluralaner. 2. The method of claim 1, wherein less than about 0.50% by weight of the isoxazoline parasiticide with respect to the total weight of the composition is administered. 3. The method of claim 1, wherein between about 0.15% and about 0.40% by weight of the isoxazoline parasiticide with respect to the total weight of the composition is administered. 4. The method of claim 1, wherein the ocular surface comprises at least one of the conjunctiva or cornea of the one or more eyes of the patient. 5. The method of claim 1, wherein the ophthalmic composition comprises castor oil. 6. A method for treating Demodex blepharitis, comprising: topically administering directly to one or more of the eye, eyelids, or eyelashes of a human patient in need of treatment thereof an effective amount of an isoxazoline parasiticide, formulated into an ophthalmic composition further comprising a pharmaceutically acceptable vehicle, wherein the ophthalmic composition is sterile and non-irritating to the eye, wherein the isoxazoline parasiticide is the sole active ingredient of the ophthalmic composition, wherein the ophthalmic composition comprises an eye drop, wherein the ophthalmic composition does not comprise tea tree oil, and wherein the isoxazoline parasiticide comprises lotilaner or fluralaner. 7. The method of claim 6, wherein the patient's eyes are closed upon topically administering the ophthalmic composition, such that the composition contacts orifices of Meibomian glands of the patient and outside of eyelid margins of the patient. 8. The method of claim 7, further comprising spreading the composition onto the eyelashes and follicles of the eyelashes. 9. The method of claim 7, further comprising spreading the composition onto the eyelashes and follicles of the eyelashes with an applicator. 10. The method of claim 6, wherein from about 0.001% to about 1% by weight of the isoxazoline parasiticide with respect to the total weight of the composition is administered. 11. The method of claim 6, comprising topically administering the ophthalmic composition at least once daily for at least about 2 weeks. 12. The method of claim 6, comprising topically administering the ophthalmic composition at least once daily for at least about 4 weeks. 13. A method for treating an ocular Demodex infestation, comprising: topically administering directly to an ocular surface of one or more eyes of a human patient in need of treatment thereof, an effective amount of an isoxazoline parasiticide, formulated into an ophthalmic composition further comprising a pharmaceutically acceptable vehicle, wherein the ophthalmic composition is sterile and non-irritating to the eye, wherein the isoxazoline parasiticide is the sole active ingredient of the ophthalmic composition, wherein the ophthalmic composition comprises an eye drop, wherein the ophthalmic composition does not comprise tea tree oil, and wherein the isoxazoline parasiticide comprises lotilaner or fluralaner. 14. The method of claim 13, further comprising receiving a first assessment of a quantity of Demodex mites on an anatomical structure of the patient, and topically administering the ophthalmic composition if the quantity of Demodex mites is greater than a predetermined value. 15. The method of claim 13, wherein the ophthalmic composition causes an abdomen and tail of Demodex mites on the patient to stop moving more quickly relative to a cephalothorax of the Demodex mites. 16. The method of claim 13, comprising administering between about 25 microliters and about 50 microliters of the eye drop to the patient at least one time daily. 17. The method of claim 13, wherein the ocular Demodex infestation comprises blepharitis. 18. The method of claim 13, wherein the ocular Demodex infestation comprises ocular rosacea. 19. The method of claim 13, wherein the ocular Demodex infestation comprises Meibomian gland dysfunction. 20. The method of claim 13, wherein the ocular Demodex infestation comprises conjunctivitis. 21. The method of claim 13, wherein the ocular Demodex infestation comprises keratitis. 22. A method for treating an ocular Demodex infestation, comprising: topically administering directly to an ocular surface of one or more eyes of a human patient in need of treatment thereof, an effective amount of an isoxazoline parasiticide, formulated into an ophthalmic composition further comprising a pharmaceutically acceptable vehicle, wherein the ophthalmic composition is sterile and non-irritating to the eye, wherein the ophthalmic composition comprises an eye drop, wherein the ophthalmic composition does not comprise tea tree oil, and wherein the isoxazoline parasiticide comprises lotilaner or fluralaner. 23. The method of claim 22, comprising administering between about 25 microliters and about 50 microliters of the eye drop to the patient at least one time daily. 24. The method of claim 22, wherein the ocular Demodex infestation comprises blepharitis. 25. The method of claim 22, wherein the ocular Demodex infestation comprises ocular rosacea. 26. The method of claim 22, wherein the ocular Demodex infestation comprises Meibomian gland dysfunction. 27. The method of claim 22, wherein the ocular Demodex infestation comprises conjunctivitis. 28. The method of claim 22, wherein the isoxazoline parasiticide comprises lotilaner.