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 the eye of a human, the method comprising topically administering to the eye of the human an emulsion at a frequency of twice a day, wherein the 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 effective in increasing tear production.
38 . The method of claim 37 , wherein the 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 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 topical ophthalmic emulsion further comprises glycerine and a buffer.
43 . The method of claim 37 , wherein the emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
44 . The method of claim 37 , wherein the emulsion comprises Pemulen in an amount of about 0.05% by weight.
45 . The method of claim 37 , wherein the 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 37 , wherein, when the emulsion is administered to an eye of a human in an effective amount in treating KCS, the blood of the human has substantially no detectable concentration of cyclosporin A.
48 . The method of claim 42 , wherein the emulsion has a pH in the range of about 7.2 to about 7.6.
49 . The method of claim 37 , wherein the 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 method of claim 37 , wherein the 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 method of claim 37 , wherein the 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 method of claim 37 , wherein the 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 method of claim 52 , wherein the adverse events include side effects.
54 . A method of treating KCS, the method comprising the step of topically administering to an eye of a human an emulsion at a frequency of twice a day, the 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;
a tonicity component or a demulcent component in an amount of about 2.2% by weight;
a buffer; and
water;
wherein the emulsion is effective in treating KCS.
55 . The method of claim 54 , wherein the buffer is sodium hydroxide.
56 . The method of claim 54 , wherein the tonicity component or the demulcent component is glycerine.
57 . The method of claim 54 , wherein, when the emulsion is administered to the eye of a human in an effective amount in treating KCS, the blood of the human has substantially no detectable concentration of the cyclosporin A.
58 . The method of claim 54 , wherein the emulsion has a pH in the range of about 7.2 to about 7.6.
59 . A method comprising:
administering an emulsion topically to the eye of a human having KCS, wherein the 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;
glycerine in an amount of about 2.2% by weight;
sodium hydroxide; and
water; and
wherein the emulsion is effective in increasing tear production in the human having KCS.
60 . The method of claim 59 , wherein the emulsion has a pH in the range of about 7.2 to about 7.6.