Ophthalmic pharmaceutical compositions and uses relating thereto
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.
1. A method of correcting presbyopia 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, including one or more stabilizers, sodium chloride, pH agent, and water, wherein the correction of presbyopia occurs via a change in pupil size.
2. The method of claim 1 , 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 administration is topical or by surgical intervention.
5. 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) 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/or
l) suffers from a higher order aberration at night or under light conditions.
6. The method of claim 1 , wherein the ophthalmic pharmaceutical composition is a slow release composition.
7. 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.
8. The method of claim 7 , wherein the ophthalmic pharmaceutical composition is an eye drop formulation.
9. 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.
10. The method of claim 1 , wherein the ophthalmic pharmaceutical composition corrects presbyopia without adversely reducing visual field.
11. The method of claim 3 , wherein the ophthalmic pharmaceutical composition is effective for up to 12 hours.
12. The method of claim 11 , wherein the ophthalmic pharmaceutical composition is effective for up to 8 hours.