Inflammatory eye disorders

Patent metadata

Field	Value
Publication number	US-9877645-B2
Application number	US-201715411803-A
Country	US
Kind code	B2
Filing date	Jan 20, 2017
Priority date	Feb 21, 2012
Publication date	Jan 30, 2018
Grant date	Jan 30, 2018

Abstract

Provided herein are methods of evaluating efficacy of a treatment in a subject having eye inflammation (e.g., a subject having dry eye syndrome) and selecting a subject for participation in a clinical study. Also provided are methods of treating a subject having eye inflammation (e.g., a subject having dry eye syndrome).

First claim

The invention claimed is:

1. A method of treating a subject having dry eye syndrome, the method comprising:
using in vitro confocal microscopy to determine a number or average density of dendritic inflammatory cells present in the center of the cornea in an eye of the subject;
comparing the number or average density of dendritic inflammatory cells present in the center of the cornea in the eye of the subject to a corresponding reference value; and
selectively administering a topical steroid solution to an eye(s) of a subject having dry eye syndrome, determined to have an elevated number or density of dendritic immune cells present in the center of the cornea as compared to the reference level; or
selectively orally or topically administering two or more immunosuppressive agents to a subject having dry eye syndrome, determined to have no substantial change or a decreased number or density of dendritic immune cells present in the center of the cornea as compared to the reference level.

2. The method of claim 1 , wherein the topical steroid solution comprises a steroid selected from the group consisting of: loteprednol etabonate, dexamethasone, hydrocortisone, prednisolone, prednisone, methylprednisolone, betamethasone, dexamethasone, triamcinolone, beclometasone, fludrocortisone, deoxycorticosterone, and aldosterone.

3. The method of claim 1 , wherein the topical steroid solution contains loteprednol etabonate.

4. The method of claim 1 , wherein the topical steroid solution is administered at least once a day.

5. The method of claim 1 , wherein at least one of the at least two immunosuppressive agents is a steroid.

6. The method of claim 5 , wherein the steroid is selected from the group consisting of: loteprednol etabonate, dexamethasone, hydrocortisone, prednisolone, prednisone, methylprednisolone, betamethasone, dexamethasone, triamcinolone, beclometasone, fludrocortisone, deoxycorticosterone, and aldosterone.

7. The method of claim 1 , wherein at least one of the two immunosuppressive agents is selected from the group consisting of: pimecrolimus, tacrolimus, sirolimus, and cyclosporine.

8. The method of claim 1 , wherein at least one of the at least two immunosuppressive agents is selected from the group consisting of: pimecrolimus, tacrolimus, sirolimus, and cyclosporine.

9. The method of claim 8 , wherein the at least one immunosuppressive agent is cyclosporine.

10. The method of claim 1 , wherein the at least two immunosuppressive agents are administered at least twice a week.

11. The method of claim 10 , wherein the at least two immunosuppressive agents are administered at least once a day.

12. The method of claim 1 , further comprising selecting a subject determined to have an elevated number or density of dendritic inflammatory cells present in the center of the cornea in the eye of the subject as compared to the corresponding reference value.

13. A method of treating a subject, the method comprising:
using in vitro confocal microscopy to determine a number or average density of dendritic inflammatory cells present in the peripheral cornea in an eye of the subject;
comparing the number or average density of dendritic inflammatory cells present in the peripheral cornea in the eye of the subject to a corresponding reference value; and
selectively topically or orally administering one or both of at least one anti-inflammatory steroid or at least one immunosuppressive agent to a subject determined to have an elevated number or elevated average density of dendritic inflammatory cells present in the peripheral cornea as compared to the corresponding reference value.

14. The method of claim 13 , wherein the subject is diagnosed as having eye inflammation.

15. The method of claim 13 , wherein the at least one anti-inflammatory steroid is selected from the group consisting of: hydrocortisone, cortisone, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, beclometasone, fludrocortisone, deoxycorticosterone, and aldosterone.

16. The method of claim 13 , wherein the at least one immunosuppressive agent is a calcineurin inhibitor.

17. The method of claim 16 , wherein the at least one calcineurin inhibitor is selected from the group consisting of: pimecrolimus, tacrolimus, sirolimus, and cyclosporine.

18. The method of claim 13 , further comprising selecting a subject determined to have an elevated number or density of dendritic inflammatory cells present in the peripheral cornea in the eye of the subject as compared to the corresponding reference value.

Assignees

• Massachusetts Eye & Ear Infirmary

Inventors

• Hamrah Pedram
• Dana Reza
• Cavalcanti Bernardo
• Cruzat Andrea

Classifications

• A61K38/13

  Cyclosporins · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title

• A61B5/4848

  Monitoring or testing the effects of treatment, e.g. of medication · CPC title

• A61P27/00

  Drugs for disorders of the senses · CPC title