Claims for Patent: 11,974,986

Summary for Patent: 11,974,986

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):	Claes Feinbaum, Franc SALAMUN, Sudhir PATEL
Assignee:	Orasis Pharmaceuticals Ltd
Application Number:	US17/386,138
Patent Claims:	1. A method of improving distance visual acuity or decreasing magnitude of higher order aberrations in a subject comprising administering to the subject a therapeutically effective amount of an ophthalmic pharmaceutical composition consisting of pilocarpine hydrochloride at a concentration of about 0.4% (w/w or w/v), sodium hyaluronate at a concentration of about 0.1% (w/w or w/v), hydroxypropyl methylcellulose at a concentration of about 0.8% (w/w or w/v), and one or more pharmaceutically acceptable carriers and/or excipients, wherein administering the composition improves distance visual acuity or decreases the magnitude of higher order aberrations. 2. The method of claim 1, wherein the one or more carriers and/or excipients comprises one or more stabilizers, and wherein the one or more stabilizers are selected from the group consisting of sodium hydrogen sulphite and/or ethylenediaminetetraacetic acids, or mixtures thereof. 3. The method of claim 1, wherein the ophthalmic pharmaceutical composition is effective for up to 24 hours and/or effective without adversely affecting night vision. 4. The method of claim 1, wherein the subject: a) is a spectacle wearer who cannot or will not use progressive or bifocal lenses; b) underwent cataract surgery; c) has mono-focal or multifocal intraocular lenses; d) uses contact lenses and does not tolerate mono-vision contact lenses; e) uses contact lenses and does not tolerate multifocal contact lenses; f) suffers from a higher order aberration after corneal surgery; g) does not tolerate a change in spectacle prescription; h) experiences a rapid change in spectacle prescription; and/or i) is at risk of falls when using progressive or bifocal lenses. 5. The method of claim 1, wherein the ophthalmic pharmaceutical composition corrects presbyopia without adversely reducing visual field. 6. The method of claim 3, wherein the ophthalmic pharmaceutical composition is effective for up to 12 hours. 7. The method of claim 6, wherein the ophthalmic pharmaceutical composition is effective for up to 8 hours. 8. The method of claim 1, wherein the distance visual acuity in the subject is uncorrected. 9. The method of claim 1, wherein the administration is topical or by surgical intervention. 10. The method of claim 1, wherein the ophthalmic pharmaceutical composition is a slow release composition. 11. The method of claim 1, wherein the ophthalmic pharmaceutical composition is in the form of a suspension, gel, ointment, injectable solution, spray, or eye drop formulation. 12. The method of claim 11, wherein the ophthalmic pharmaceutical composition is an eye drop formulation. 13. The method of claim 1, wherein the ophthalmic pharmaceutical composition is suitable for topical delivery to a subject's eye or tissue surrounding the eye. 14. The method of claim 1, wherein the improvement in distance visual acuity or decrease in higher order aberrations is measured by a change in pupil size. 15. The method of claim 1, wherein the one or more carriers and/or excipients comprises one or more stabilizers, sodium chloride, a pH agent, and water.