Methods of providing therapeutic effects using cyclosporin components
View Patent ↗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. A method of treating dry eye disease, the method comprising topically administering to the eye of a human in need thereof 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, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; and
wherein the topical ophthalmic emulsion is effective in treating dry eye disease.
2. The method of claim 1 , wherein the 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 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 topical ophthalmic emulsion further comprises glycerine and a buffer.
7. The method of claim 1 , wherein the emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
8. The method of claim 1 , wherein the 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 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 1 , wherein, when the emulsion is administered to an eye of a human, the blood of the human has substantially no detectable concentration of cyclosporin A.
12. The method of claim 6 , wherein the emulsion has a pH in the range of about 7.2 to about 7.6.
13. The method of claim 1 , wherein the emulsion is as substantially therapeutically effective as a second emulsion administered to a human in need thereof at a frequency of twice a day, the second emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
14. The method of claim 1 , wherein the emulsion achieves at least as much therapeutic effectiveness as a second emulsion administered to a human in need thereof a frequency of twice a day, the second emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
15. The method of claim 1 , 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 a second emulsion that contains only 50% as much castor oil.
16. The method of claim 1 , wherein the emulsion, when administered to the eye of a human, demonstrates a reduction in adverse events in the human, relative to a second emulsion administered to a human in need thereof a frequency of twice a day, the second emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
17. The method of claim 16 , wherein the adverse events are side effects.
18. A method of reducing side effects in a human being treated for dry eye syndrome, the method comprising the step of topically administering to the eye of the human in need thereof an emulsion at a frequency of twice a day, 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;
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.
19. The method of claim 18 , wherein the buffer is sodium hydroxide.
20. The method of claim 18 , wherein the tonicity component or the demulcent component is glycerine.
21. The method of claim 18 , wherein, when the emulsion is administered to the eye of a human for treating dry eye syndrome, the blood of the human has substantially no detectable concentration of the cyclosporin A.
22. The method of claim 18 , wherein the emulsion is effective in treating dry eye disease.
23. A method of treating dry eye disease, the method comprising the step of topically administering to an eye of a human in need thereof 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;
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 the emulsion is effective in treating dry eye disease.
24. The method of claim 23 , wherein the emulsion has a pH in the range of about 7.2 to about 7.6.