Claims for Patent: 11,951,153
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Summary for Patent: 11,951,153
| Title: | Topical cyclosporine-containing formulations and uses thereof |
| Abstract: | Provided herein are formulations for topical ophthalmic formulations containing 0.087-0.093 wt % of cyclosporine, and methods of making and using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also included herein are methods of treating or preventing diseases or conditions, such as ocular diseases or conditions. |
| Inventor(s): | Sidney L. Weiss, Ashim K. Mitra, Eugene J. McNally |
| Assignee: | Ocular Technologies SARL, Sun Pharmaceutical Industries Ltd |
| Application Number: | US17/935,177 |
| Patent Claims: |
1. A method of treating an inflammatory ocular disease in a subject, comprising administering to the subject an ophthalmic aqueous topical formulation consisting of: 0.087-0.093 wt % cyclosporine; about 1.0 wt % hydrogenated 40 polyoxyl castor oil; about 0.05 wt % octoxynol-40; about 0.3 wt % povidone; about 0.05 wt % sodium chloride; phosphate buffer, adjusted to a pH of about 5 to about 8 with sodium hydroxide and/or hydrochloric acid; and water. 2. The method of claim 1, wherein the administering is twice daily. 3. The method of claim 1, wherein the inflammatory ocular disease is keratoconjunctivitis sicca. 4. The method of claim 1, wherein the cyclosporine is 0.09 wt % of the formulation. 5. The method of claim 1, wherein the cyclosporine is present in one or more nanomicelles in the formulation. 6. The method of claim 1, wherein pH of the formulation is about 6.6 to about 7.0. 7. A method of increasing tear production in a subject in need thereof, comprising administering to the subject an ophthalmic aqueous topical formulation consisting of: 0.087-0.093 wt % cyclosporine; about 1.0 wt % hydrogenated 40 polyoxyl castor oil; about 0.05 wt % octoxynol-40; about 0.3 wt % povidone; about 0.05 wt % sodium chloride; phosphate buffer, adjusted to a pH of about 5 to about 8 with sodium hydroxide and/or hydrochloric acid; and water. 8. The method of claim 7, wherein the administering is twice daily. 9. The method of claim 7, wherein the tear production is measured by a Schirmer test score from baseline. 10. The method of claim 9, wherein the subject has about 17.9% likelihood of a ≥10 mm increase in the Schirmer test score. 11. The method of claim 7, wherein the cyclosporine is 0.09 wt % of the formulation. 12. The method of claim 7, wherein the cyclosporine is present in one or more nanomicelles in the formulation. 13. The method of claim 7, wherein pH of the formulation is about 6.6 to about 7.0. 14. A method of treating keratoconjunctivitis sicca in a subject, comprising administering twice daily to the subject an ophthalmic aqueous topical formulation consisting of: 0.087-0.093 wt % cyclosporine; about 1.0 wt % hydrogenated 40 polyoxyl castor oil; about 0.05 wt % octoxynol-40; about 0.3 wt % povidone; about 0.05 wt % sodium chloride; phosphate buffer, adjusted to a pH of about 5 to about 8 with sodium hydroxide and/or hydrochloric acid; and water. 15. The method of claim 14, wherein the cyclosporine is 0.09 wt % of the formulation. 16. The method of claim 14, wherein pH of the formulation is about 6.6 to about 7.0. |
