# US 9,872,901 B2 · Therapeutic compositions for treatment of ocular inflammatory disorders

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- Number: US 9,872,901 B2
- Document ID: US9872901B2
- Status: Granted
- Kind: B2
- Application number: 15/063,088
- Filed: 2016-03-07
- Published: 2016-12-15
- Granted: 2018-01-23
- Earliest claimed: 2008-01-09
- Assignees: The Schepens Eye Research Institute, Inc.
- Applicants: The Schepens Eye Research Institute, Inc.
- Inventors: Reza Dana; Sunil Chauhan
- Web page: https://patentgrep.com/patent/US9872901B2

## CPC

- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/0051: {Ocular inserts or implants}
- A61K 31/724: Cyclodextrins
- A61K 31/728: Hyaluronic acid
- A61K 38/1793: {for cytokines; for lymphokines; for interferons}
- A61K 38/20: Interleukins [IL]
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 27/04: Artificial tears; Irrigation solutions
- A61P 27/14: Decongestants or antiallergics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/54: Interleukins [IL]
- C07K 16/244: {Interleukins [IL]}
- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/75: Agonist effect on antigen
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

The invention comprises a composition with means to inhibit the function of the inflammatory cytokine IL-17 and methods for using this composition to treat IL-17-mediated ocular inflammatory disorders. The invention also discloses devices for delivering this composition to the eye.

## Claims

### Claim 1

A method for reducing the severity of dry eye syndrome comprising
identifying a subject characterized as suffering from dry eye syndrome;
topically administering directly to an eye of a subject a composition that inhibits binding of an inflammatory interleukin-17 (IL-17) cytokine to an IL-17 receptor; and
inhibiting or reducing eye dryness associated with said dry eye syndrome,
thereby reducing the severity of said dry eye syndrome, wherein said dry eye syndrome is caused by bone marrow transplant.

### Claim 2 (depends on 1)

The method of claim 1, wherein said identifying step comprises detection of a sign or symptom selected from the group consisting of eye dryness, scratching, stinging, itching, burning, irritation, pain, redness, inflammation, discharge, and excessive watering, and wherein said method inhibits or reduces the severity of at least one of said signs or symptoms.

### Claim 3 (depends on 1)

The method of claim 1, wherein said method comprises sequential or simultaneous administration of a composition that inhibits binding of an inflammatory IL-17 cytokine to an IL-17 receptor and a secondary composition.

### Claim 4 (depends on 1)

The method of claim 1, wherein the form of said composition is a solid, an ointment, a gel, a liquid, an aerosol, a mist, a polymer, a contact lens, a film, an emulsion, or a suspension.

### Claim 5 (depends on 1)

The method of claim 1, wherein said method does not comprise systemic administration or substantial dissemination to non-ocular tissue.

### Claim 6 (depends on 1)

The method of claim 1, wherein said composition further comprises a compound selected from the group consisting of a physiologically acceptable salt, poloxamer analogs with carbopol, carbopol/HPMC, carbopol-methyl cellulose, a mucolytic agent, carboxymethylcellulose (CMC), hyaluronic acid, cyclodextrin, and petroleum.

### Claim 7 (depends on 1)

The method of claim 1, wherein said method comprises administration of both a composition that inhibits binding of an inflammatory IL-17 cytokine to an IL-17 receptor and a second composition comprising one or more inflammatory antagonist(s).

### Claim 8 (depends on 1)

The method of claim 1, wherein said composition comprises:
(a) a monoclonal or polyclonal antibody;
(b) an antibody that targets an intracellular or extracellular IL-17 cytokine or IL-17 receptor;
(c) an antibody that binds to at least one intracellular or extracellular sequence of an IL-17 cytokine or IL-17 receptor;
(d) a single-chain antibody;
(e) a humanized, recombinant, or chimeric antibody;
(f) an antibody conjugated directly or indirectly to a compound that inhibits or modifies the activity of an IL-17 cytokine or an IL-17 receptor or
(g) a composition that inhibits or modifies the transcription, transcript stability, translation, modification, localization, secretion, or function of a polynucleotide or polypeptide encoding an inflammatory interleukin-17 cytokine or an IL-17 receptor.

### Claim 9 (depends on 1)

The method of claim 1, wherein said composition inhibits an activity of an inflammatory cytokine selected from the group consisting of IL-17A, IL-17B, IL-17C, IL-17D, IL-17E, and IL-17F.

### Claim 10 (depends on 1)

The method of claim 1, wherein said composition inhibits an activity of an inflammatory cytokine receptor selected from the group consisting of IL-17RA, IL-17RB, IL-17RC, IL-17RD, IL-17RE, and IL-17RF.

### Claim 11

A method for reducing the severity of dry eye syndrome comprising
identifying a subject characterized as suffering from dry eye syndrome;
topically administering directly to an eye of a subject a composition that inhibits binding of an inflammatory interleukin-17 (IL-17) cytokine to an IL-17 receptor; and
inhibiting or reducing eye dryness associated with said dry eye syndrome,
thereby reducing the severity of said dry eye syndrome, wherein said subject has or has been subjected to a bone marrow transplant.

### Claim 12 (depends on 11)

The method of claim 11, wherein said identifying step comprises detection of a sign or symptom selected from the group consisting of eye dryness, scratching, stinging, itching, burning, irritation, pain, redness, inflammation, discharge, and excessive watering, and wherein said method inhibits or reduces the severity of at least one of said signs or symptoms.

### Claim 13 (depends on 11)

The method of claim 11, wherein said method comprises sequential or simultaneous administration of a composition that inhibits binding of an inflammatory IL-17 cytokine to an IL-17 receptor and a secondary composition.

### Claim 14 (depends on 11)

The method of claim 11, wherein the form of said composition is a solid, an ointment, a gel, a liquid, an aerosol, a mist, a polymer, a contact lens, a film, an emulsion, or a suspension.

### Claim 15 (depends on 11)

The method of claim 11, wherein said method does not comprise systemic administration or substantial dissemination to non-ocular tissue.

### Claim 16 (depends on 11)

The method of claim 11, wherein said composition further comprises a compound selected from the group consisting of a physiologically acceptable salt, poloxamer analogs with carbopol, carbopol/HPMC, carbopol-methyl cellulose, a mucolytic agent, carboxymethylcellulose (CMC), hyaluronic acid, cyclodextrin, and petroleum.

### Claim 17 (depends on 11)

The method of claim 11, wherein said method comprises administration of both a composition that inhibits binding of an inflammatory IL-17 cytokine to an IL-17 receptor and a second composition comprising one or more inflammatory antagonist(s).

### Claim 18 (depends on 11)

The method of claim 11, wherein said composition comprises:
(a) a monoclonal or polyclonal antibody;
(b) an antibody that targets an intracellular or extracellular IL-17 cytokine or IL-17 receptor;
(c) an antibody that binds to at least one intracellular or extracellular sequence of an IL-17 cytokine or IL-17 receptor;
(d) a single-chain antibody;
(e) a humanized, recombinant, or chimeric antibody;
(f) an antibody conjugated directly or indirectly to a compound that inhibits or modifies the activity of an IL-17 cytokine or an IL-17 receptor or
(g) a composition that inhibits or modifies the transcription, transcript stability, translation, modification, localization, secretion, or function of a polynucleotide or polypeptide encoding an inflammatory interleukin-17 cytokine or an IL-17 receptor.

### Claim 19 (depends on 11)

The method of claim 11, wherein said composition inhibits an activity of an inflammatory cytokine selected from the group consisting of IL-17A, IL-17B, IL-17C, IL-17D, IL-17E, and IL-17F.

### Claim 20 (depends on 11)

The method of claim 11, wherein said composition inhibits an activity of an inflammatory cytokine receptor selected from the group consisting of IL-17RA, IL-17RB, IL-17RC, IL-17RD, IL-17RE, and IL-17RF.