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 topical ophthalmic emulsion for treating an eye of a human, wherein the topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, Pemulen, water, and castor oil in an amount of about 1.25% by weight; and
wherein the topical ophthalmic emulsion is therapeutically effective in treating dry eye disease.
38 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion further comprises a tonicity agent or a demulcent component.
39 . The topical ophthalmic emulsion of claim 38 , wherein the tonicity agent or the demulcent component is glycerine.
40 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion further comprises a buffer.
41 . The topical ophthalmic emulsion of claim 40 , wherein the buffer is sodium hydroxide.
42 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion further comprises glycerine and a buffer.
43 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
44 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion comprises Pemulen in an amount of about 0.05% by weight.
45 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion further comprises glycerine in an amount of about 2.2% by weight and a buffer.
46 . The topical ophthalmic emulsion of claim 45 , wherein the buffer is sodium hydroxide.
47 . The topical ophthalmic emulsion of claim 37 , wherein, when the topical ophthalmic emulsion is administered to an eye of a human in an effective amount in treating dry eye disease, the blood of the human has substantially no detectable concentration of cyclosporin A.
48 . The topical ophthalmic emulsion of claim 42 , wherein the topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.
49 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion is as substantially therapeutically effective as an emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
50 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion achieves at least as much therapeutic effectiveness as an emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
51 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion breaks down more quickly in the eye of a human, once administered to the eye of the human, thereby reducing vision distortion in the eye of the human as compared to an emulsion that contains only 50% as much castor oil.
52 . The topical ophthalmic emulsion of claim 37 , wherein the topical ophthalmic emulsion, when administered to the eye of a human, demonstrates a reduction in adverse events in the human, relative to an emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
53 . The topical ophthalmic emulsion of claim 52 , wherein the adverse events include side effects.
54 . A topical ophthalmic emulsion for treating an eye of a human, wherein the topical ophthalmic emulsion is therapeutically effective in treating dry eye and wherein the 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;
Pemulen 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.
55 . The topical ophthalmic emulsion of claim 54 , wherein the buffer is sodium hydroxide.
56 . The topical ophthalmic emulsion of claim 54 , wherein the tonicity component or the demulcent component is glycerine.
57 . The topical ophthalmic emulsion of claim 54 , wherein, when the topical ophthalmic emulsion is administered to an eye of a human in an effective amount in treating dry eye disease, the blood of the human has substantially no detectable concentration of the cyclosporin A.
58 . The topical ophthalmic emulsion of claim 54 , wherein the topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.
59 . A topical ophthalmic emulsion for treating an eye of a human, the topical ophthalmic emulsion comprising:
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;
Pemulen in an amount of about 0.05% by weight;
glycerine in an amount of about 2.2% by weight;
sodium hydroxide; and
water;
wherein the emulsion is therapeutically effective in treating dry eye disease.
60 . The topical ophthalmic emulsion of claim 59 , wherein the topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.