IP Library › Granted Patent US 12,336,971
Granted Patent B2
US 12,336,971 · App. 18/510,437 · Granted Jun 24, 2025

Ophthalmic pharmaceutical compositions and uses thereof

Inventor: Anjali Joshi (Durham, NC)
Assignee: Alcon Inc.
A61K31/167A61K9/0048A61K47/02A61K47/38A61K47/44A61P27/04
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Quick Facts
Patent No.
US 12,336,971
App. No.
18/510,437
Granted
Jun 24, 2025
Kind
B2
Abstract

Provided herein are ophthalmic pharmaceutical compositions comprising (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide (WS-12) for effectively treating dry eye in a subject in need thereof, effectively reducing dry eye in a subject in need thereof, effectively reducing the likelihood of dry eye in a subject in need thereof, or for treating, preventing, or ameliorating signs or symptoms of dry eye in a subject in need thereof.

Claims (32)

1. A method of treating dry eye or reducing the likelihood of dry eye in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a liquid ophthalmic pharmaceutical composition, wherein the liquid ophthalmic pharmaceutical composition comprises a viscosity of less than 5 cP, and the liquid ophthalmic pharmaceutical composition comprises:

about 0.003% w/v (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide;

about 0.14% w/v hypromellose;

about 3.0% w/v polyoxyl 35 castor oil;

about 0.78% w/v sodium dihydrogen phosphate dihydrate buffer;

about 0.55% w/v NaCl;

a pH of about 7; and

water.

2. A method of treating an ophthalmic disease or disorder involving tear production or reducing the signs or symptoms of the ophthalmic disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a liquid ophthalmic pharmaceutical composition, wherein the liquid ophthalmic pharmaceutical composition comprises a viscosity of less than 5 cP, and the liquid ophthalmic pharmaceutical composition comprises:

about 0.003% w/v (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide;

about 0.14% w/v hypromellose;

about 3.0% w/v polyoxyl 35 castor oil;

about 0.78% w/v sodium dihydrogen phosphate dihydrate buffer;

about 0.55% w/v NaCl;

a pH of about 7; and

water.

3. A method of treating dry eye or reducing the likelihood of dry eye in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a liquid ophthalmic pharmaceutical composition, wherein the liquid ophthalmic pharmaceutical composition comprises a viscosity of less than 5 cP, and the liquid ophthalmic pharmaceutical composition comprises:

about 0.0014% w/v (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide;

about 0.14% w/v hypromellose;

about 3.0% w/v polyoxyl 35 castor oil;

about 0.78% w/v sodium dihydrogen phosphate dihydrate buffer;

about 0.55% w/v NaCl;

a pH of about 7; and

water.

4. A method of treating an ophthalmic disease or disorder involving tear production or reducing the signs or symptoms of the ophthalmic disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a liquid ophthalmic pharmaceutical composition, wherein the liquid ophthalmic pharmaceutical composition comprises a viscosity of less than 5 cP, and the liquid ophthalmic pharmaceutical composition comprises:

about 0.0014% w/v (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide;

about 0.14% w/v hypromellose;

about 3.0% w/v polyoxyl 35 castor oil;

about 0.78% w/v sodium dihydrogen phosphate dihydrate buffer;

about 0.55% w/v NaCl;

a pH of about 7; and

water.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 24, 2024
From: AERIE PHARMACEUTICALS, INC.
To: ALCON INC.
Reel/Frame 067822/0168 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2023
From: JOSHI, ANJALI
To: AERIE PHARMACEUTICALS, INC.
Reel/Frame 065576/0664 →
Continuity (3)
Continuation 18082844 · Dec 16, 2022
Provisional Application 63290781 · Dec 17, 2021
Related Publication 20240091179A1 · Mar 21, 2024
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