Claims for Patent: 10,610,518

Summary for Patent: 10,610,518

Title:	Presbyopia treatments
Abstract:	Described herein are methods and compositions for the treatment of ocular conditions and for the improvement of vision parameters using pharmaceutically acceptable ophthalmic pilocarpine formulations. A nonlimiting example of an ocular condition that may be treated with the methods and compositions disclosed herein is presbyopia.
Inventor(s):	Robinson; Michael R. (Huntington Beach, CA), Dibas; Mohammed (Corona, CA), Giyanani; Jaya (Irvine, CA), Gore; Anuradha (Aliso Viejo, CA), Lee; Sungwook (Orange, CA), Liu; Haixia (Irvine, CA), Morgan; Aileen (Rancho Santa Margarita, CA), Zhou; Jihao (Rancho Santa Margarita, CA)
Assignee:	ALLERGAN, INC. (Irvine, CA)
Application Number:	16/393,175
Patent Claims:	1. A method of treating an ocular condition in a patient in need thereof, comprising administering to the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration of 1.0 to 1.5% w/v, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.03 to 0.37% w/v sodium chloride, hydrochloric acid and/or sodium hydroxide, and water; wherein the pharmaceutically acceptable ophthalmic composition does not comprise any viscosity enhancing polymers; wherein the formulation is administered topically to at least one eye of the patient; wherein the ocular condition is selected from the group consisting of presbyopia, hyperopia, mydriasis, anisocoria, accommodative esotropia, myopia, and astigmatism; and, wherein administration of the pharmaceutically acceptable ophthalmic composition results in a lower incidence of at least one of ocular blurring, ocular discomfort, eye pain, brow ache, blurry vision, light sensitivity, stinging, and itching, compared to administration of a second ophthalmic composition comprising pilocarpine and a polymer. 2. The method of claim 1, wherein the ocular condition is presbyopia. 3. The method of claim 1, wherein the ocular condition is hyperopia. 4. The method of claim 1, wherein the pharmaceutically acceptable ophthalmic composition is administered to both eyes of the patient. 5. The method of claim 1, wherein the pharmaceutically acceptable ophthalmic composition is administered to the dominant eye of the patient. 6. The method of claim 1, wherein the pharmaceutically acceptable ophthalmic composition is administered once daily. 7. The method of claim 1, wherein the pharmaceutically acceptable ophthalmic composition is administered twice daily. 8. The method of claim 1, wherein the pharmaceutically acceptable ophthalmic composition has a duration of effect of at least six hours. 9. The method of claim 1, wherein pilocarpine hydrochloride is the sole active ingredient in the pharmaceutically acceptable ophthalmic composition. 10. The method of claim 1, wherein the composition comprises 1.25% w/v pilocarpine hydrochloride. 11. The method of claim 1, wherein the ocular condition is presbyopia, and wherein the composition consists essentially of 1.25% w/v pilocarpine hydrochloride, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride, with a pH of 3.0-5.5. 12. A method for improvement of near vision in a patient with presbyopia in need thereof, comprising administering to an eye of the patient a pharmaceutically acceptable composition comprising pilocarpine hydrochloride as the sole active agent at a concentration from 1.0 to 1.5% w/v, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.03 to 0.37% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride; wherein the pharmaceutically acceptable composition does not comprise any viscosity enhancing polymers; and, wherein the administration of the pharmaceutically acceptable composition to the patient results in a lower incidence of at least one adverse event compared to the administration of a second composition comprising pilocarpine hydrochloride and a viscosity-enhancing polymer, and wherein the adverse events are selected from the group consisting of ocular blurring, ocular discomfort, eye pain, brow ache, blurry vision, light sensitivity, ocular stinging, and ocular itching. 13. The method of claim 12, where the pharmaceutically acceptable composition is administered once daily. 14. The method of claim 12, wherein the pharmaceutically acceptable composition comprises 1.25% w/v pilocarpine hydrochloride. 15. The method of claim 1, wherein the composition comprises 1.1875% w/v to 1.3125% w/v pilocarpine hydrochloride. 16. The method of claim 1, wherein the composition comprises 1.0% w/v pilocarpine hydrochloride, 1% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.14% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride, with a pH of 3.0-5.5. 17. The method of claim 1, wherein the composition comprises 1.25% w/v pilocarpine hydrochloride, 1% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride, with a pH of 3.0-5.5. 18. The method of claim 1, wherein the composition comprises 1.5% w/v pilocarpine hydrochloride, 1% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.03% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride, with a pH of 3.0-5.5. 19. The method of claim 12, wherein the composition comprises 1.25% w/v pilocarpine hydrochloride, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride, with a pH of 3.0-5.5. 20. The method of claim 12, wherein the composition consists essentially of 1.25% w/v pilocarpine hydrochloride, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, and 0.0075% w/v benzalkonium chloride, with a pH of 3.0-5.5.