IP Library Granted Patent US 11,197,847
Granted Patent B2
US 11,197,847 · App. 17/193,453 · Granted Dec 14, 2021

Isoxazoline parasiticide formulations and methods for treating blepharitis

Inventors: Bobak Robert Azamian (Newport Coast, CA); Douglas Michael Ackermann (Reno, NV); Shawn D. Hickok (Aliso Viejo, CA); Joseph G. Vehige (Irvine, CA)
Assignee: Tarsus Pharmaceuticals, Inc.
A61K31/422A61K9/0048A61K9/08A61K47/26A61P27/02A61P33/14
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Quick Facts
Patent No.
US 11,197,847
App. No.
17/193,453
Granted
Dec 14, 2021
Kind
B2
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.

Claims (45)

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 comprises an eye drop,

wherein the isoxazoline parasiticide is the sole active ingredient of the ophthalmic composition, and

wherein the isoxazoline parasiticide comprises lotilaner.

2. The method of claim 1 , wherein about 0.30% 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 0.20% 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 comprises an eye drop, and

wherein the isoxazoline parasiticide comprises lotilaner.

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 6 , wherein from about 0.15% to about 0.40% by weight of the isoxazoline parasiticide with respect to the total weight of the composition is administered.

9. The method of claim 6 , comprising topically administering the ophthalmic composition at least once daily for at least about 4 weeks.

10. The method of claim 6 , comprising topically administering the ophthalmic composition at least twice daily for at least about 6 weeks.

11. 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,

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,

wherein topically administering occurs twice daily for at least 4 weeks.

12. The method of claim 11 , wherein the isoxazoline parasiticide is the sole active ingredient of the ophthalmic composition.

13. The method of claim 11 , wherein the ocular Demodex infestation comprises blepharitis.

14. The method of claim 11 , wherein the ocular Demodex infestation comprises ocular rosacea.

15. The method of claim 11 , wherein the ocular Demodex infestation comprises Meibomian gland dysfunction.

16. The method of claim 11 , wherein the ocular Demodex infestation comprises ocular surface disease.

17. The method of claim 11 , wherein the ocular Demodex infestation comprises dry eye disease.

18. The method of claim 11 , wherein the ocular Demodex infestation comprises madarosis.

19. A method for treating an ocular Demodex infestation, comprising:

topically administering 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 comprises an eye drop, and

wherein the isoxazoline parasiticide comprises lotilaner.

20. The method of claim 19 , comprising administering between about 25 microliters and about 50 microliters of the eye drop to the patient at least one time daily.

21. The method of claim 19 , comprising administering between about 25 microliters and about 50 microliters of the eye drop to the patient twice daily for at least six weeks.

22. The method of claim 19 , wherein the ocular Demodex infestation comprises blepharitis or Meibomian gland dysfunction.

23. The method of claim 19 ,

wherein the ocular Demodex infestation comprises blepharitis or Meibomian gland dysfunction,

wherein about 0.30% by weight of the isoxazoline parasiticide with respect to the total weight of the composition is administered,

wherein the isoxazoline parasiticide is the sole active ingredient of the ophthalmic composition,

wherein the ophthalmic composition does not comprise tea tree oil,

wherein the ophthalmic composition further comprises hydrogenated castor oil, and

wherein the method further comprises administering between about 25 microliters and about 50 microliters of the eye drop to the patient two times daily for at least six weeks.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Apr 19, 2024
From: TARSUS PHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 067171/0968 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2021
From: AZAMIAN, BOBAK ROBERT; ACKERMANN, DOUGLAS MICHAEL; HICKOK, SHAWN D.; VEHIGE, JOSEPH G.
To: TARSUS PHARMACEUTICALS, INC.
Reel/Frame 057947/0240 →
Continuity (8)
Continuation 17099531 · Nov 16, 2020
Continuation 16221390 · Dec 14, 2018
Provisional Application 62599213 · Dec 15, 2017
Provisional Application 62615855 · Jan 10, 2018
Provisional Application 62626612 · Feb 5, 2018
Provisional Application 62689787 · Jun 25, 2018
Provisional Application 62746498 · Oct 16, 2018
Related Publication 20210196689A1 · Jul 1, 2021
Cited By (5)
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