Inflammatory eye disorders

Patent metadata

Field	Value
Publication number	US-9549966-B2
Application number	US-201314379380-A
Country	US
Kind code	B2
Filing date	Feb 21, 2013
Priority date	Feb 21, 2012
Publication date	Jan 24, 2017
Grant date	Jan 24, 2017

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:
determining the 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;
selectively administering 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, a topical steroid solution;
selectively orally or topically administering to 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 a reference level, two or more immunosuppressive agents; or
selectively topically or orally administering 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 a corresponding reference value, at least one anti-inflammatory steroid and/or at least one immunosuppressive agent.

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

4. 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.

5. The method of claim 1 , wherein the determining is performed using in vitro confocal microscopy.

6. 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.

7. The method of claim 1 , wherein the method comprises selectively topically or orally administering 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 a corresponding reference value, at least one anti-inflammatory steroid and/or at least one immunosuppressive agent.

8. The method of claim 7 , 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.

9. The method of claim 7 , wherein the at least one immunosuppressive agent is a calcineurin inhibitor.

10. The method of claim 7 , further comprising:
determining the number or average density of dendritic inflammatory cells present in the peripheral cornea in an eye of the subject; and
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.

11. The method of claim 10 , wherein the determining is performed using in vitro confocal microscopy.

12. The method of claim 7 , 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 Primary

  Cyclosporins · CPC title

• A61B5/0068

  Confocal scanning · CPC title

• A61B3/101 Primary

  for examining the tear film · CPC title

• G02B21/0028

  specially adapted for specific applications, e.g. for endoscopes, ophthalmoscopes, attachments to conventional microscopes · CPC title

• A61B3/1025

  for confocal scanning · CPC title