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Claims for Patent: 8,629,111

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Claims for Patent: 8,629,111

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:13/967,163
Patent Claims: 1. A topical ophthalmic emulsion for treating an eye of a human comprising 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 cyclosporin A is the only peptide present in the topical ophthalmic emulsion.

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

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

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

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

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

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

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

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

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

11. The topical ophthalmic emulsion of claim 1, wherein, when the topical ophthalmic emulsion is administered to an eye of a human, the blood of the human has substantially no detectable concentration of cyclosporin A.

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

13. 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; 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 topical ophthalmic emulsion has a pH in the range of about 7.2 to about 7.6 and wherein cyclosporin A is the only peptide present in the topical ophthalmic emulsion.

14. The topical ophthalmic emulsion of claim 13, wherein the buffer is sodium hydroxide.

15. The topical ophthalmic emulsion of claim 13, wherein the tonicity component or the demulcent component is glycerine.

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

17. The topical ophthalmic emulsion of claim 13, wherein the topical ophthalmic emulsion is effective in treating keratoconjunctivitis sicca.

18. 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; acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight; glycerine in an amount of about 2.2% by weight; sodium hydroxide; and water; wherein cyclosporin A is the only peptide present in the topical ophthalmic emulsion.

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

20. The topical ophthalmic emulsion of claim 1, wherein the topical ophthalmic emulsion is therapeutically effective in treating dry eye.

21. The topical ophthalmic emulsion of claim 1, wherein the topical ophthalmic emulsion is therapeutically effective in treating keratoconjunctivitis sicca.

22. The topical ophthalmic emulsion of claim 1, wherein the topical ophthalmic emulsion is therapeutically effective in increasing tear production.

23. The topical ophthalmic emulsion of claim 13, wherein the topical ophthalmic emulsion is therapeutically effective in treating dry eye.

24. The topical ophthalmic emulsion of claim 13, wherein the topical ophthalmic emulsion is therapeutically effective in increasing tear production.

25. The topical ophthalmic emulsion of claim 18, wherein the topical ophthalmic emulsion is therapeutically effective in treating dry eye.

26. The topical ophthalmic emulsion of claim 18, wherein the topical ophthalmic emulsion is therapeutically effective in treating keratoconjunctivitis sicca.

27. The topical ophthalmic emulsion of claim 18, wherein the topical ophthalmic emulsion is therapeutically effective in increasing tear production.
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