Claims for Patent: 11,285,134

Summary for Patent: 11,285,134

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):	Michael R. Robinson, Mohammed DIBAS, Jaya Giyanani, Anuradha Gore, Sungwook Lee, Haixia Liu, Aileen Morgan, Jihao Zhou
Assignee:	Allergan Inc
Application Number:	US16/791,039
Patent Claims:	1. A method for the treatment of presbyopia in a patient in need thereof, comprising topically administering once daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition comprising 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride. 2. The method of claim 1, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity. 3. The method of claim 1, wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity. 4. The method of claim 1, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity. 5. The method of claim 1, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 6. The method of claim 1, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity. 7. The method of claim 1, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 8. The method of any one of claims 2 to 7, wherein the improvement from baseline has a duration of effect of at least two hours. 9. The method of any one of claims 2 to 7, wherein the improvement from baseline has a duration of effect of at least six hours. 10. A method for the treatment of presbyopia in a patient in need thereof, comprising topically administering once daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition consisting of 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride. 11. The method of claim 10, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity. 12. The method of claim 10, wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity. 13. The method of claim 10, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity. 14. The method of claim 10, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 15. The method of claim 10, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity. 16. The method of claim 10, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 17. The method of any one of claims 11 to 16, wherein the improvement from baseline has a duration of effect of at least two hours. 18. The method of any one of claims 11 to 16, wherein the improvement from baseline has a duration of effect of at least six hours. 19. A method for the treatment of presbyopia in a patient in need thereof, comprising topically administering twice daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition comprising 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride. 20. The method of claim 19, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity. 21. The method of claim 19, wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity. 22. The method of claim 19, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity. 23. The method of claim 19, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 24. The method of claim 19, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity. 25. The method of claim 19, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 26. The method of any one of claims 20 to 25, wherein the improvement from baseline has a duration of effect of at least two hours. 27. The method of any one of claims 20 to 25, wherein the improvement from baseline has a duration of effect of at least six hours. 28. A method for the treatment of presbyopia in a patient in need thereof, comprising topically administering twice daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition consisting of 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride. 29. The method of claim 28, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity. 30. The method of claim 28, wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity. 31. The method of claim 28, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity. 32. The method of claim 28, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 33. The method of claim 28, wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity. 34. The method of claim 28, wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity. 35. The method of any one of claims 29 to 34, wherein the improvement from baseline has a duration of effect of at least two hours. 36. The method of any one of claims 29 to 34, wherein the improvement from baseline has a duration of effect of at least six hours.