Claims for Patent: 12,653,824

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Summary for Patent: 12,653,824

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:	US19/169,836
Patent Claims:	1. A nasal spray bottle containing an aqueous liquid pharmaceutical formulation for administration into a nasal cavity of a human, the formulation comprising a solution of varenicline or a pharmaceutically acceptable varenicline salt and one or more pharmaceutically acceptable inactive ingredients, wherein varenicline is the single therapeutic agent in the formulation, the concentration of varenicline in the formulation is between about 0.1 mg/mL and about 2 mg/mL, and one spray of the formulation from the bottle contains between 10 micrograms and 50 micrograms of varenicline. 2. The nasal spray bottle of claim 1, wherein the formulation comprises a buffer selected from a phosphate buffer and a phosphate-citrate buffer. 3. The nasal spray bottle of claim 2, wherein the formulation comprises a phosphate buffer, wherein the pH of the phosphate buffer is around 7.0. 4. The nasal spray bottle of claim 2, wherein the formulation comprises a phosphate-citrate buffer, wherein the pH of the phosphate-citrate buffer is from around 5.0 to around 6.0. 5. The nasal spray bottle of claim 1, wherein the formulation is preservative-free. 6. The nasal spray bottle of claim 5, wherein the formulation comprises a salt for regulating osmotic pressure. 7. The nasal spray bottle of claim 1, wherein the volume of one spray from the bottle is 50 microliters. 8. The nasal spray bottle of claim 7, wherein the formulation comprises a buffer selected from a phosphate buffer and a phosphate-citrate buffer. 9. The nasal spray bottle of claim 8, wherein the formulation comprises a phosphate buffer and the pH of the phosphate buffer is around 7.0. 10. The nasal spray bottle of claim 8, wherein the formulation comprises a phosphate-citrate buffer and the pH of the phosphate-citrate buffer is from around 5.0 to around 6.0. 11. The nasal spray bottle of claim 7, wherein the formulation is preservative-free. 12. The nasal spray bottle of claim 11, wherein the formulation comprises a salt for regulating osmotic pressure. 13. The nasal spray bottle of claim 8, for local administration into the nasal cavity of the human.