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Claims for Patent: 8,642,556

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Claims for Patent: 8,642,556

Title:Methods of providing therapeutic effects using cyclosporin components
Abstract: 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.
Inventor(s): Acheampong; Andrew (Irvine, CA), Tang-Liu; Diane D. (Las Vegas, NV), Chang; James N. (Newport Beach, CA), Power; David F. (Hubert, NC)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:13/967,189
Patent Claims: 1. A first topical ophthalmic emulsion for treating an eye of a human, 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; and wherein the first topical ophthalmic emulsion is therapeutically effective in treating dry eye disease; and wherein the first topical ophthalmic emulsion provides overall efficacy substantially equal to a second topical ophthalmic 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.

2. The first topical ophthalmic emulsion of claim 1, wherein the first topical ophthalmic emulsion further comprises a tonicity agent or a demulcent component.

3. The first topical ophthalmic emulsion of claim 2, wherein the tonicity agent or the demulcent component is glycerine.

4. The first topical ophthalmic emulsion of claim 1, wherein the first topical ophthalmic emulsion further comprises a buffer.

5. The first topical ophthalmic emulsion of claim 4, wherein the buffer is sodium hydroxide.

6. The first topical ophthalmic emulsion of claim 1, wherein the first topical ophthalmic emulsion further comprises glycerine and a buffer.

7. The first topical ophthalmic emulsion of claim 1, wherein the first topical ophthalmic emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.

8. The first topical ophthalmic emulsion of claim 1, wherein the first topical ophthalmic emulsion comprises acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight.

9. The first topical ophthalmic emulsion of claim 1, wherein the first topical ophthalmic emulsion further comprises glycerine in an amount of about 2.2% by weight and a buffer.

10. The first topical ophthalmic emulsion of claim 9, wherein the buffer is sodium hydroxide.

11. The first topical ophthalmic emulsion of claim 1, wherein, when the first 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.

12. The first topical ophthalmic emulsion of claim 6, wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.

13. A first topical ophthalmic emulsion for treating an eye of a human, 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; and wherein the first topical ophthalmic emulsion is therapeutically effective in treating dry eye disease and wherein the first topical ophthalmic emulsion achieves at least as much therapeutic effectiveness as a second topical ophthalmic 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.

14. A first topical ophthalmic emulsion for treating an eye of a human, 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; and wherein the first 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 a second topical ophthalmic emulsion that contains only about 50% as much castor oil as the first topical ophthalmic emulsion.

15. A first topical ophthalmic emulsion for treating an eye of a human, 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; and wherein the first topical ophthalmic emulsion, when administered to the eye of a human, demonstrates a reduction in adverse events in the human, relative to a second topical ophthalmic 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.

16. The first topical ophthalmic emulsion of claim 15, wherein the adverse events are side effects.

17. The first topical ophthalmic emulsion of claim 16, wherein the side effects are selected from the group consisting of visual distortion and eye irritation.

18. The first topical ophthalmic emulsion of claim 13, wherein, when the first topical ophthalmic emulsion is administered to an eye of a human, the blood of the human has substantially no detectable concentration of cyclosporin A.

19. The first topical ophthalmic emulsion of claim 14, wherein, when the first topical ophthalmic emulsion is administered to an eye of a human, the blood of the human has substantially no detectable concentration of cyclosporin A.

20. The first topical ophthalmic emulsion of claim 15, wherein, when the first topical ophthalmic emulsion is administered to an eye of a human, the blood of the human has substantially no detectable concentration of cyclosporin A.
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