Claims for Patent: 12,576,080

Summary for Patent: 12,576,080

Title:	Use of varenicline for treating ocular conditions
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:	US19/169,843
Patent Claims:	1. A method of treating dry eye in a human comprising locally administering a spray of a liquid pharmaceutical formulation comprising between 25 micrograms and 50 micrograms of varenicline into a nostril twice daily, wherein the liquid pharmaceutical formulation comprises varenicline and the concentration of varenicline in the formulation is between about 0.5 mg/mL and about 1 mg/mL. 2. The method of claim 1, wherein the liquid pharmaceutical formulation does not include a preservative. 3. The method of claim 1, wherein the liquid pharmaceutical formulation comprises a phosphate buffer and the pH of the liquid pharmaceutical formulation is around 7.0. 4. A method of treating dry eye in a human in need thereof comprising locally administering a spray of a liquid pharmaceutical formulation into a nostril, wherein the formulation comprises varenicline and one or more pharmaceutically acceptable inactive ingredients and the concentration of varenicline in the formulation is between about 0.1 mg/mL and about 10 mg/mL, and wherein the amount of varenicline in the spray is between 5 micrograms and 100 micrograms. 5. The method of claim 4, wherein the concentration of varenicline in the formulation is between about 0.2 mg/mL and about 1 mg/mL. 6. The method of claim 5, wherein the concentration of varenicline in the formulation is between about 0.5 mg/mL and about 1 mg/mL. 7. The method of claim 4, wherein the amount of varenicline in the spray is between 5 micrograms and 50 micrograms. 8. The method of claim 7, wherein the concentration of varenicline in the formulation is between about 0.2 mg/mL and about 1 mg/mL. 9. The method of claim 8, wherein the concentration of varenicline in the formulation is between about 0.5 mg/mL and about 1 mg/mL. 10. The method of claim 9, wherein the formulation does not include a preservative. 11. The method of claim 4, wherein the amount of varenicline in the spray is between 25 micrograms and 50 micrograms. 12. The method of claim 11, wherein the concentration of varenicline in the formulation is between about 0.2 mg/mL and about 1 mg/mL. 13. The method of claim 12, wherein the concentration of varenicline in the formulation is between about 0.5 mg/mL and about 1 mg/mL. 14. The method of claim 13, wherein the formulation does not include a preservative. 15. The method of claim 4, wherein the local administration is repeated in a second nostril. 16. The method of claim 8, wherein the local administration is repeated in a second nostril. 17. The method of claim 10, wherein the local administration is repeated in a second nostril. 18. The method of claim 12, wherein the local administration is repeated in a second nostril. 19. The method of claim 4, wherein the liquid pharmaceutical formulation comprises a phosphate buffer. 20. The method of claim 19, wherein the liquid pharmaceutical formulation has a pH around 7.0. 21. The method of claim 10, wherein the liquid pharmaceutical formulation comprises a phosphate buffer. 22. The method of claim 21, wherein the liquid pharmaceutical formulation has a pH around 7.0. 23. The method of claim 13, wherein the liquid pharmaceutical formulation comprises a phosphate buffer. 24. The method of claim 23, wherein the liquid pharmaceutical formulation has a pH around 7.0. 25. The method of claim 24, wherein the liquid pharmaceutical formulation does not include a preservative. 26. The method of claim 4, wherein the formulation comprises a phosphate-citrate buffer, and wherein the formulation has a pH from around 5.0 to around 6.0. 27. The method of claim 10, wherein the formulation comprises a phosphate-citrate buffer, and wherein the formulation has a pH from around 5.0 to around 6.0. 28. The method of claim 14, wherein the formulation comprises a phosphate-citrate buffer, and wherein the formulation has a pH from around 5.0 to around 6.0. 29. The method of claim 14, wherein the local administration is repeated in a second nostril.