Claims for Patent: 9,867,810

Summary for Patent: 9,867,810

Title:	Ophthalmic pharmaceutical compositions and uses relating thereto
Abstract:	The disclosure relates to ophthalmic pharmaceutical compositions comprising pilocarpine or a pharmaceutically acceptable salt. Aspects of the disclosure further relate to uses and preparations of ophthalmic pharmaceutical compositions comprising pilocarpine or a pharmaceutically acceptable salt, for correcting presbyopia and other ocular conditions in a subject.
Inventor(s):	Feinbaum Claes, Salamun Franc, Patel Sudhir
Assignee:	Orasis Pharmaceuticals Ltd.
Application Number:	US15680967
Patent Claims:	2. The ophthalmic pharmaceutical composition of claim 1 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.3. The ophthalmic pharmaceutical composition of claim 1 , further comprising diclofenac or a pharmaceutically acceptable salt thereof at a concentration of 0.001% (w/w or w/v) to 0.090% (w/w or w/v) claim 1 , or ketorolac or a pharmaceutically acceptable salt thereof at a concentration of 0.01% (w/w or w/v) to 0.60% (w/w or w/v).4. The ophthalmic pharmaceutical composition of claim 3 , wherein the diclofenac salt is diclofenac sodium claim 3 , or wherein the ketorolac salt is ketorolac tromethamine.5. The ophthalmic pharmaceutical composition of claim 4 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).6. The ophthalmic pharmaceutical composition of claim 5 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).7. The ophthalmic pharmaceutical composition of claim 2 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.8. The ophthalmic pharmaceutical composition of claim 7 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.9. The ophthalmic pharmaceutical composition of claim 1 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 1 , preservative claim 1 , and/or solvent.10. The ophthalmic pharmaceutical composition of claim 1 , further comprising an isotonic agent claim 1 , a wetting agent claim 1 , a buffer claim 1 , a stabilizer claim 1 , a pH agent claim 1 , a solubilizer claim 1 , a thickening agent claim 1 , and/or a dispersing agent.11. The ophthalmic pharmaceutical composition of claim 1 , wherein the ophthalmic pharmaceutical composition is effective for correction of presbyopia for up to 24 hours.13. The method of claim 12 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.14. The method of claim 12 , wherein the ophthalmic pharmaceutical composition further comprises diclofenac or a pharmaceutically acceptable salt thereof at a concentration of 0.001% (w/w or w/v) to 0.090% (w/w or w/v) claim 12 , or ketorolac or a pharmaceutically acceptable salt thereof at a concentration of 0.01% (w/w or w/v) to 0.60% (w/w or w/v).15. The method of claim 14 , wherein the diclofenac salt is diclofenac sodium claim 14 , or wherein the ketorolac salt is ketorolac tromethamine.16. The method of claim 15 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).17. The method of claim 16 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).18. The method of claim 13 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1 (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.19. The method of claim 18 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.20. The method of claim 13 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 13 , preservative claim 13 , and/or solvent.21. The method of claim 13 , wherein the ophthalmic pharmaceutical composition further comprises an isotonic agent claim 13 , a wetting agent claim 13 , a buffer claim 13 , a stabilizer claim 13 , a pH agent claim 13 , a solubilizer claim 13 , a thickening agent claim 13 , and/or a dispersing agent.22. The method of claim 13 , wherein the ophthalmic pharmaceutical composition is effective for correction of presbyopia for up to 24 hours.23. The method of claim 13 , wherein the administration is topical or by surgical intervention.24. The method of claim 13 , wherein the subject:a) is a spectacle wearer who cannot or will not use progressive or bifocal lenses;b) underwent cataract surgery;c) developed presbyopia after a corneal procedure;d) has mono-focal or multifocal intraocular lenses;e) uses contact lenses and does not tolerate mono-vision contact lenses;f) uses contact lenses and does not tolerate multifocal contact lenses;g) suffers from a higher order aberration after corneal surgery;h) suffers from hyperopia or tropias;i) does not tolerate a change in spectacle prescription;j) experiences a rapid change in spectacle prescription;k) is at risk of falls when using progressive or bifocal lenses; and/orl) suffers from a higher order aberration at night or under dull light conditions.26. The method of claim 25 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.27. The method of claim 26 , wherein the ophthalmic pharmaceutical composition further comprises sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.9% (w/w or w/v).28. The method of claim 27 , wherein the ophthalmic pharmaceutical composition further comprises diclofenac or a pharmaceutically acceptable salt thereof at a concentration of 0.001% (w/w or w/v) to 0.090% (w/w or w/v) claim 27 , or ketorolac or a pharmaceutically acceptable salt thereof at a concentration of 0.01% (w/w or w/v) to 0.60% (w/w or w/v).29. The method of claim 28 , wherein the diclofenac salt is diclofenac sodium claim 28 , or wherein the ketorolac salt is ketorolac tromethamine.30. The method of claim 29 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).31. The method of claim 30 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).32. The method of claim 26 , wherein the ophthalmic pharmaceutical composition further comprises:(1) sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.9% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.090% (w/w or w/v), or mixtures thereof; or(2) sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.9% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.60% (w/w or w/v), or mixtures thereof.33. The method of claim 26 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.34. The method of claim 33 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.35. The method of claim 25 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 25 , preservative claim 25 , and/or solvent.36. The method of claim 25 , wherein the ophthalmic pharmaceutical composition further comprises an isotonic agent claim 25 , a wetting agent claim 25 , a buffer claim 25 , a stabilizer claim 25 , a pH agent claim 25 , a solubilizer claim 25 , a thickening agent claim 25 , and/or a dispersing agent.38. The method of claim 37 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.39. The method of claim 37 , wherein the ophthalmic pharmaceutical composition further comprises diclofenac or a pharmaceutically acceptable salt thereof at a concentration of 0.001% (w/w or w/v) to 0.090% (w/w or w/v) claim 37 , or ketorolac or a pharmaceutically acceptable salt thereof at a concentration of 0.01% (w/w or w/v) to 0.60% (w/w or w/v).40. The method of claim 39 , wherein the diclofenac salt is diclofenac sodium claim 39 , or wherein the ketorolac salt is ketorolac tromethamine.41. The method of claim 40 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).42. The method of claim 41 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).43. The method of claim 38 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.44. The method of claim 43 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.45. The method of claim 38 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 38 , preservative claim 38 , and/or solvent.46. The method of claim 38 , wherein the ophthalmic pharmaceutical composition further comprises an isotonic agent claim 38 , a wetting agent claim 38 , a buffer claim 38 , a stabilizer claim 38 , a pH agent claim 38 , a solubilizer claim 38 , a thickening agent claim 38 , and/or a dispersing agent.47. The method of claim 38 , wherein the administration is topical or by surgical intervention.48. The method of claim 38 , wherein the subject:a) is a spectacle wearer who cannot or will not use progressive or bifocal lenses;b) underwent cataract surgery;c) developed presbyopia after a corneal procedure;d) has mono-focal or multifocal intraocular lenses;e) uses contact lenses and does not tolerate mono-vision contact lenses;f) uses contact lenses and does not tolerate multifocal contact lenses;g) suffers from a higher order aberration after corneal surgery;h) suffers from hyperopia or tropias;i) does not tolerate a change in spectacle prescription;j) experiences a rapid change in spectacle prescription;k) is at risk of falls when using progressive or bifocal lenses; and/orl) suffers from a higher order aberration at night or under dull light conditions.50. The ophthalmic pharmaceutical composition of claim 49 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.51. The ophthalmic pharmaceutical composition of claim 50 , further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.9% (w/w or w/v).52. The ophthalmic pharmaceutical composition of claim 50 , wherein the diclofenac salt is diclofenac sodium claim 50 , or wherein the ketorolac salt is ketorolac tromethamine.53. The ophthalmic pharmaceutical composition of claim 52 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).54. The ophthalmic pharmaceutical composition of claim 53 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).55. The ophthalmic pharmaceutical composition of claim 50 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.56. The ophthalmic pharmaceutical composition of claim 55 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.57. The ophthalmic pharmaceutical composition of claim 49 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 49 , preservative claim 49 , and/or solvent.58. The ophthalmic pharmaceutical composition of claim 49 , further comprising an isotonic agent claim 49 , a wetting agent claim 49 , a buffer claim 49 , a stabilizer claim 49 , a pH agent claim 49 , a solubilizer claim 49 , a thickening agent claim 49 , and/or a dispersing agent.59. The ophthalmic pharmaceutical composition of claim 49 , wherein the ophthalmic pharmaceutical composition is effective for correction of presbyopia for up to 24 hours.61. The method of claim 60 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.62. The method of claim 61 , wherein the ophthalmic pharmaceutical composition further comprises sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.9% (w/w or w/v).63. The method of claim 61 , wherein the diclofenac salt is diclofenac sodium claim 61 , or wherein the ketorolac salt is ketorolac tromethamine.64. The method of claim 63 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).65. The method of claim 64 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).66. The method of claim 61 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1 (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.67. The method of claim 66 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.68. The method of claim 61 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 61 , preservative claim 61 , and/or solvent.69. The method of claim 61 , wherein the ophthalmic pharmaceutical composition further comprises an isotonic agent claim 61 , a wetting agent claim 61 , a buffer claim 61 , a stabilizer claim 61 , a pH agent claim 61 , a solubilizer claim 61 , a thickening agent claim 61 , and/or a dispersing agent.70. The method of claim 61 , wherein the ophthalmic pharmaceutical composition is effective for correction of presbyopia for up to 24 hours.71. The method of claim 61 , wherein the administration is topical or by surgical intervention.72. The method of claim 61 , wherein the subject:a) is a spectacle wearer who cannot or will not use progressive or bifocal lenses;b) underwent cataract surgery;c) developed presbyopia after a corneal procedure;d) has mono-focal or multifocal intraocular lenses;e) uses contact lenses and does not tolerate mono-vision contact lenses;f) uses contact lenses and does not tolerate multifocal contact lenses;g) suffers from a higher order aberration after corneal surgery;h) suffers from hyperopia or tropias;i) does not tolerate a change in spectacle prescription;j) experiences a rapid change in spectacle prescription;k) is at risk of falls when using progressive or bifocal lenses; and/orl) suffers from a higher order aberration at night or under dull light conditions.74. The method of claim 73 , wherein the pilocarpine salt is pilocarpine hydrochloride or pilocarpine nitrate.75. The method of claim 74 , wherein the ophthalmic pharmaceutical composition further comprises sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.9% (w/w or w/v).76. The method of claim 74 , wherein the diclofenac salt is diclofenac sodium claim 74 , or wherein the ketorolac salt is ketorolac tromethamine.77. The method of claim 76 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v).78. The method of claim 77 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and diclofenac sodium at a concentration of 0.006% (w/w or w/v); or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), sodium hyaluronate at a concentration of 0.1% (w/w or w/v), and ketorolac tromethamine at a concentration of 0.50% (w/w or w/v).79. The method of claim 74 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or diclofenac sodium at a concentration of 0.001% (w/w or w/v) to 0.012% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.1% (w/w or w/v) to 0.4% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.1% (w/w or w/v) to 1.2% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.01% (w/w or w/v) to 0.2% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.01% (w/w or w/v) to 0.50% (w/w or w/v), or mixtures thereof.80. The method of claim 79 , wherein the ophthalmic pharmaceutical composition comprises:(1) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), diclofenac sodium at a concentration of 0.006% (w/w or w/v), or mixtures thereof; or(2) pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.2% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of 0.8% (w/w or w/v), and further comprising sodium hyaluronate at a concentration of 0.1% (w/w or w/v), or ketorolac tromethamine at a concentration of 0.50% (w/w or w/v), or mixtures thereof.81. The method of claim 74 , wherein the ophthalmic pharmaceutical composition comprises a pharmaceutically acceptable diluent claim 74 , preservative claim 74 , and/or solvent.82. The method of claim 74 , further comprising an isotonic agent claim 74 , a wetting agent claim 74 , a buffer claim 74 , a stabilizer claim 74 , a pH agent claim 74 , a solubilizer claim 74 , a thickening agent claim 74 , and/or a dispersing agent.83. The method of claim 74 , wherein the administration is topical or by surgical intervention.84. The method of claim 74 , wherein the subject:a) is a spectacle wearer who cannot or will not use progressive or bifocal lenses;b) underwent cataract surgery;c) developed presbyopia after a corneal procedure;d) has mono-focal or multifocal intraocular lenses;e) uses contact lenses and does not tolerate mono-vision contact lenses;f) uses contact lenses and does not tolerate multifocal contact lenses;g) suffers from a higher order aberration after corneal surgery;h) suffers from hyperopia or tropias;i) does not tolerate a change in spectacle prescription;j) experiences a rapid change in spectacle prescription;k) is at risk of falls when using progressive or bifocal lenses; and/orl) suffers from a higher order aberration at night or under dull light conditions.