Claims for Patent: 11,224,598

Summary for Patent: 11,224,598

Title:	Methods of increasing lacrimal proteins
Abstract:	Described herein are methods and pharmaceutical formulations for treating dry eye disease.
Inventor(s):	Ackermann, Jr.; Douglas Michael (Reno, NV), Loudin; James (Houston, TX), Mandell; Kenneth J. (Lexington, MA)
Assignee:	Oyster Point Pharma, Inc. (Princeton, NJ)
Application Number:	16/566,237
Patent Claims:	1. A method of increasing the amount or concentration of one or more lacrimal proteins produced in an individual in need thereof, comprising nasally administering between 5 micrograms and 1000 micrograms of varenicline to the individual in need thereof, wherein varenicline is provided in a pharmaceutical formulation formulated for nasal administration, and the pharmaceutical formulation comprises between about 0.1 mg/mL and about 10 mg/mL of varenicline. 2. The method of claim 1, wherein the one or more lacrimal proteins are epithelial growth factor, lactoferin, lacritin, prolactin, adrenocorticotropic, leucine enkephalin, ALS2CL, ARHGEF19, KIAA1109, PLXNA1, POLG, WIPI1, ZMIZ2 or other proteins of the tear proteome. 3. The method of claim 1, wherein varenicline is administered prior to or after LASIK surgery. 4. The method of claim 1, comprising nasally administering between 5 micrograms and 600 micrograms of varenicline to the individual in need thereof. 5. The method of claim 1, comprising nasally administering between 5 micrograms and 100 micrograms of varenicline to the individual in need thereof. 6. The method of claim 1, comprising nasally administering between 100 micrograms and 750 micrograms of varenicline to the individual in need thereof. 7. The method of claim 1, wherein varenicline is administered at least once daily. 8. The method of claim 1, wherein varenicline is administered at least twice daily. 9. The method of claim 1, wherein varenicline is administered at least once weekly. 10. The method of claim 1, wherein varenicline is nasally administered as a liquid, suspension, aerosol, gel, ointment, dry powder, cream, paste, lotion, balm, or nasal spray. 11. The method of claim 1, wherein varenicline is nasally administered by a syringe, dropper, bottle nebulizer, atomization pump, inhaler, powder spray device, vaporizer, patch, medicated stick, pipette, jet of liquid, or nasal spray bottle. 12. The method of claim of 1, wherein the individual in need thereof has one or more of the signs and symptoms of dry eye disease. 13. The method of claim of 1, wherein the individual in need thereof has one or more of the symptoms comprising itchiness, dryness, photophobia, blurriness, pain, sticky feeling, burning, stinging, and foreign body sensation. 14. The method of claim 1, wherein the pharmaceutical formulation is preservative-free. 15. The method of claim 1, wherein varenicline is provided as a preservative-free nasal spray. 16. The method of claim 1, wherein the individual in need thereof has a Schirmer tear test score of .ltoreq.10 mm/5 minutes in at least one eye prior to administration of varenicline. 17. The method of claim 16, wherein the Schirmer tear test is performed with topical anesthetic. 18. The method of claim 1, wherein the pharmaceutical formulation comprises between about 0.2 mg/mL and about 3 mg/mL of varenicline. 19. The method of claim 1, wherein the pharmaceutical formulation comprises about 0.5 mg/mL, about 1 mg/mL, or about 2 mg/mL of varenicline.