# US 12,005,063 B2 · Medicament for preventing and/or treating dry eye

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- Number: US 12,005,063 B2
- Document ID: US12005063B2
- Status: Granted
- Kind: B2
- Application number: 17/722,947
- Filed: 2022-04-18
- Published: 2023-03-23
- Granted: 2024-06-11
- Earliest claimed: 2021-09-15
- Assignees: Santen Pharmaceutical Co., Ltd.; Boehringer Ingelheim International GmbH
- Applicants: Santen Pharmaceutical Co., Ltd.; Boehringer Ingelheim International GMBH
- Inventors: Kenji Oki; Takashi Nagano; Nagayoshi Asano; Koushi Fujisawa
- Web page: https://patentgrep.com/patent/US12005063B2

## CPC

- A61K 31/536: ortho- or peri-condensed with carbocyclic ring systems
- A61K 31/538: ortho- or peri-condensed with carbocyclic ring systems
- A61P 27/02: Ophthalmic agents
- A61P 27/04: Artificial tears; Irrigation solutions
- 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

## Abstract

A compound useful for preventing or treating dry eye and a medicament for preventing and/or treating dry eye comprising the same which does not substantially impact on the intraocular pressure are provided. A method of preventing and/or treating dry eye in a subject in need thereof, comprising administering a therapeutically effective amount of olodaterol or a salt thereof to the subject is also provided.

## Claims

### Claim 1

A method of treating dry eye in a subject in need thereof, comprising administering a therapeutically effective amount of olodaterol hydrochloride to the subject.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the dry eye accompanies corneal and conjunctival epithelium disorder caused by at least one selected from the group consisting of superficial punctate keratopathy, corneal epithelium defect, corneal erosion, corneal ulcer, conjunctival epithelium defect, keratoconjunctivitis sicca, superior limbic keratoconjunctivitis, filamentary keratoconjunctivitis, non-infectious keratitis, and non-infectious conjunctivitis.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the dry eye is a disease caused by at least one selected from the group consisting of tear film instability, lacrimal hyposecretion, xerophthalmia, tear deficiency, keratoconjunctivitis sicca, lacrimal gland dysfunction, meibomian gland dysfunction, VDT (Visual Display Terminal) operation, use of contact lenses, tear abnormalities, and keratoconjunctivitis.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in a concentration of 0.1% (w/v) or less.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in a concentration of 0.01% (w/v) or less.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in a concentration of 0.00001 to 0.1% (w/v).

### Claim 7 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in a concentration of 0.00001 to 0.01% (w/v).

### Claim 8 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in a concentration of 0.00001 to 0.005% (w/v).

### Claim 9 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in a concentration of 0.00001 to 0.001% (w/v).

### Claim 10 (depends on 1)

The method according to claim 1, wherein the olodaterol hydrochloride is administered in the form of an eye drop.

### Claim 11 (depends on 1)

The method according to claim 1, wherein administering the olodaterol hydrochloride does not substantially increase and/or reduce intraocular pressure.