# US 11,306,140 B2 · Therapeutics for ocular immunoinflammatory diseases

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- Number: US 11,306,140 B2
- Document ID: US11306140B2
- Status: Granted
- Kind: B2
- Application number: 16/068,300
- Filed: 2017-01-06
- Published: 2019-01-10
- Granted: 2022-04-19
- Earliest claimed: 2016-01-07
- Assignees: The Schepens Eye Research Institute, Inc.
- Applicants: The Schepens Eye Research Institute, Inc.
- Inventors: Reza Dana; Sunil Chauhan; Yihe Chen
- Web page: https://patentgrep.com/patent/US11306140B2

## CPC

- C07K 16/244: {Interleukins [IL]}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 27/04: Artificial tears; Irrigation solutions
- A61K 9/0051: {Ocular inserts or implants}
- A61K 2039/505: {comprising antibodies}
- A61L 2300/426: Immunomodulating agents, i.e. cytokines, interleukins, interferons
- A61L 2430/16: for reconstruction of eye parts, e.g. intraocular lens, cornea
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Methods and compositions for reducing the activity or number of memory Th17 cells in ocular tissue, and for treatment and/or prevention of ocular immunoinflammatory diseases are described.

## Claims

### Claim 1

A method for treating a subject afflicted with Dry Eye Disease (DED), comprising locally administering to an eye of the subject a composition consisting of a neutralizing anti-IL-15R antibody or an antibody that binds to IL-15, or a neutralizing anti-IL-7R antibody or an antibody that binds to IL-7, and an ophthalmically acceptable vehicle.

### Claim 2 (depends on 1)

The method of claim 1, wherein treating the subject afflicted with the ocular immunoinflammatory disorder comprises inhibiting the survival or proliferation of a Th17 cell in an eye tissue.

### Claim 3 (depends on 1)

The method of claim 1, wherein said subject suffers from a sandy or gritty feeling as if something is in the eye, eye dryness, heavy eyelids, stinging, itching, burning, irritation, pain, redness, inflammation, discharge, inability to cry when emotionally stressed, eye fatigue, blurred vision, or excessive watering, and wherein said method inhibits or reduces the severity of the sandy or gritty feeling as if something is in the eye, eye dryness, heavy eyelids, stinging, itching, burning, irritation, pain, redness, inflammation, discharge, inability to cry when emotionally stressed, eye fatigue, blurred vision, or excessive watering.

### Claim 4 (depends on 1)

The method of claim 1, wherein:
(a) the composition is in the form of a solid, an ointment, a gel, a liquid, an aerosol, a mist, a polymer, a contact lens, a film, an emulsion, or a suspension;
(b) said composition is administered topically;
(c) said method does not comprise systemic administration to non-ocular tissue of the composition; or
(d) the composition is administered by the subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein the number of memory Th17 cells in the eye of the subject is reduced after the composition is administered.

### Claim 6 (depends on 1)

The method of claim 1, wherein a symptom of the ocular immunoinflammatory disorder is reduced
(a) within 5, 15, 30, or 60 minutes after administering the composition begins; or
(b) within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 days after administering the composition begins.

### Claim 7 (depends on 1)

The method of claim 1, wherein the composition is administered to the eye of the subject
(a) less than 1, 2, 3, 4, 5, or 6 times per day;
(b) about 1, 2, 3, 4, 5, 6, or 7 times per week; or
(c) once daily.

### Claim 8 (depends on 1)

The method of claim 1, wherein:
(a) the compound that inhibits IL-7 signal transduction comprises an antibody that binds to IL-7; or
(b) the compound that inhibits IL-15 signal transduction comprises an antibody that binds to IL-15.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition consists of a neutralizing anti-IL-7R antibody or an antibody that binds to IL-7, and an ophthalmically acceptable excipient.
