METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
1 - 36 . (canceled)
37 . A method of increasing tear production in a human eye, the method comprising topically administering to a human eye in need thereof a first topical ophthalmic emulsion at a frequency of twice a day. wherein the first topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight;
wherein the method provides an overall increase in tear production substantially equal to administration of a second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day. the second emulsion comprising cyclosporin A in an amount of about 0.1% by weight and castor oil in an amount of about 1.25% by weight; and
wherein the method results in substantially no detectable concentration of cyclosporin A in the blood of the human.
38 . The method of claim 37 , wherein the first topical ophthalmic emulsion further comprises a tonicity agent or a demulcent component.
39 . The method of claim 38 , wherein the tonicity agent or the demulcent component is glycerine.
40 . The method of claim 37 , wherein the first topical ophthalmic emulsion further comprises a buffer.
41 . The method of claim 40 , wherein the buffer is sodium hydroxide.
42 . The method of claim 37 , wherein the first topical ophthalmic emulsion further comprises glycerine and a buffer.
43 . The method of claim 37 , wherein the first topical ophthalmic emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
44 . The method of claim 37 , wherein the first topical ophthalmic emulsion comprises acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight.
45 . The method of claim 37 , wherein the first topical ophthalmic emulsion further comprises glycerine in an amount of about 2.2% by weight and a buffer.
46 . The method of claim 45 , wherein the buffer is sodium hydroxide.
47 . The method of claim 42 , wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.
48 . The method of claim 37 , wherein the method is therapeutically effective to treat dry eye disease.
49 . A method of increasing tear production in a human eye, the method comprising topically administering to a human eye in need thereof a first topical ophthalmic emulsion at a frequency of twice a day, wherein the first topical ophthalmic emulsion comprises:
cyclosporin A in an amount of about 0.05% by weight;
castor oil in an amount of about 1.25% by weight;
polysorbate 80 in an amount of about 1.0% by weight;
acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight;
a tonicity component or a demulcent component in an amount of about 2.2% by weight;
a buffer, and
water,
wherein the method achieves a substantially equal increase in tear production as administration of a second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day, the second emulsion being identical to the first topical ophthalmic emulsion except that the second topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.1% by weight, and
wherein the method results in substantially no detectable concentration of cyclosporin A in the blood of the human.
50 . The method of claim 49 , wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.
51 . The method of claim 49 , wherein the method is effective in enhancing lacrimal gland tearing.
52 . The method of claim 49 , wherein the method is therapeutically effective to treat dry eye disease.