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Last Updated: December 16, 2025

Claims for Patent: 11,903,941

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Summary for Patent: 11,903,941

Title:	Compositions and use of varenicline for treating dry eye
Abstract:	Described herein are methods and pharmaceutical formulations for treating dry eye disease.
Inventor(s):	Douglas Michael Ackermann, JR., James LOUDIN, Kenneth J. Mandell
Assignee:	Oyster Point Pharma Inc
Application Number:	US17/543,505
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,903,941
Patent Claims:	1. A method of treating dry eye in a human, comprising nasally administering between 5 micrograms and 1000 micrograms of varenicline per day, wherein varenicline is in a liquid pharmaceutical formulation comprising a concentration of varenicline between about 0.1 mg/mL and about 10 mg/mL. 2. The method of claim 1, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.2 mg/mL and 1 mg/mL. 3. The method of claim 1, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.5 mg/mL and 1 mg/mL. 4. The method of claim 1, comprising nasally administering between 5 micrograms and 600 micrograms of varenicline per day. 5. The method of claim 4, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.2 mg/mL and 1 mg/mL. 6. The method of claim 4, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.5 mg/mL and 1 mg/mL. 7. The method of claim 6, wherein the liquid pharmaceutical formulation is administered as a nasal spray. 8. The method of claim 7, wherein the liquid pharmaceutical formulation does not include a preservative. 9. The method of claim 1, wherein the liquid pharmaceutical formulation is administered as a nasal spray. 10. The method of claim 9, wherein the liquid pharmaceutical formulation does not include a preservative. 11. The method of claim 4, wherein the liquid pharmaceutical formulation is administered as a nasal spray. 12. The method of claim 11, wherein the liquid pharmaceutical formulation does not include a preservative. 13. A method of treating dry eye in a human, comprising nasally administering between 5 micrograms and 100 micrograms of varenicline twice daily, wherein varenicline is in a liquid pharmaceutical formulation comprising a concentration of varenicline between about 0.1 mg/mL and about 10 mg/mL. 14. The method of claim 13, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.2 mg/mL and 1 mg/mL. 15. The method of claim 13, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.5 mg/mL and 1 mg/mL. 16. The method of claim 13, comprising nasally administering between 25 micrograms and 100 micrograms of varenicline twice daily. 17. The method of claim 16, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.2 mg/mL and 1 mg/mL. 18. The method of claim 16, wherein the liquid pharmaceutical formulation comprises a concentration of varenicline between 0.5 mg/mL and 1 mg/mL. 19. The method of claim 18, wherein the liquid pharmaceutical formulation is administered as a nasal spray. 20. The method of claim 19, wherein the liquid pharmaceutical formulation does not include a preservative. 21. The method of claim 13, wherein the liquid pharmaceutical formulation is administered as a nasal spray. 22. The method of claim 21, wherein the liquid pharmaceutical formulation does not include a preservative. 23. The method of claim 16, wherein the liquid pharmaceutical formulation is administered as a nasal spray. 24. The method of claim 9, wherein the liquid pharmaceutical formulation does not include a preservative.

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