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Claims for Patent: 9,248,191

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Claims for Patent: 9,248,191

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. (San Clemente, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:14/222,478
Patent Claims: 1. A method of treating dry eye disease, 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 005% 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 is therapeutically effective in treating dry eye disease; wherein the method provides overall efficacy 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.

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

3. The method of claim 2, wherein the tonicity agent or the demulcent component is glycerine.

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

5. The method of claim 4, wherein the buffer is sodium hydroxide.

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

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

8. The method 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 method 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 method of claim 9, wherein the buffer is sodium hydroxide.

11. The method of claim 2, wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.

12. The method of claim 1, wherein substantially no detectable concentration of cyclosporin A in the blood of the human means that the concentration of cyclosporin A in the blood of the human is less than about 0.1 ng/ml.

13. A method of enhancing tearing 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 is therapeutically effective in treating dry eye disease and wherein the method achieves at least as much therapeutic efficacy 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 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 a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml.

14. The method of claim 13, wherein the first topical ophthalmic emulsion comprises acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight, polysorbate 80 in an amount of about 1.0% by weight, and wherein the first topical ophthalmic emulsion further comprises glycerine in an amount of about 2.2% by weight and a buffer.

15. The method of claim 14, wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.

16. The method of claim 13, wherein the method is effective in enhancing lacrimal gland tearing.

17. A method of treating dry eye disease, 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; and wherein the first topical ophthalmic emulsion breaks down more quickly in the human eye, once administered to the human eye, thereby reducing vision distortion in the human eye as compared to a second topical ophthalmic emulsion that contains only about 50% as much castor oil as the first topical ophthalmic emulsion.

18. The method of claim 17, wherein the first topical ophthalmic emulsion comprises acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight, polysorbate 80 in an amount of about 1.0% by weight, and wherein the first topical ophthalmic emulsion further comprises glycerine in an amount of about 2.2% by weight and a buffer.

19. The method of claim 18, wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.

20. The method of claim 19, wherein the method results in a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml.

21. A method of restoring tearing, 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 demonstrates a reduction in adverse events in the human, compared to administration of a second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day, the 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; and wherein the method achieves at least as much therapeutic efficacy as administration of the second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day.

22. The method of claim 21, wherein the method results in a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml.

23. The method of claim 21, wherein the adverse events are selected from the group consisting of visual distortion and eye irritation.

24. The method of claim 21, wherein the first topical ophthalmic emulsion comprises acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight, polysorbate 80 in an amount of about 1.0% by weight, and wherein the first topical ophthalmic emulsion further comprises glycerine in an amount of about 2.2% by weight and a buffer.

25. The method of claim 24, wherein the first topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6.

26. The method of claim 21, wherein the method is effective in restoring lacrimal gland tearing.

27. The method of claim 21, wherein the adverse events are selected from the group consisting of visual distortion and eye irritation and wherein the method results in a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml.
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