Pharmaceutical preparation containing pyridyl aminoacetic acid compound

Patent metadata

Field	Value
Publication number	US-12290511-B2
Application number	US-202318314909-A
Country	US
Kind code	B2
Filing date	May 10, 2023
Priority date	Dec 28, 2017
Publication date	May 6, 2025
Grant date	May 6, 2025

Abstract

The present invention aims to find a pharmaceutical preparation which treats or prevents glaucoma or ocular hypertension and is effective for patients with inadequate efficacies of glaucoma or ocular hypertension therapeutic agents. It has been found that omidenepag, an ester thereof, or a salt thereof has an excellent intraocular pressure lowering efficacy on patients with inadequate efficacies of other glaucoma or ocular hypertension therapeutic agents. Therefore, the omidenepag, the ester thereof, or the salt thereof of the present invention is useful as a pharmaceutical preparation which can treat or prevent glaucoma or ocular hypertension even in patients with inadequate efficacies of other glaucoma or ocular hypertension therapeutic agents.

First claim

What is claimed is:

1. A method of treating glaucoma or ocular hypertension, comprising: administering to a patient a pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof as an active ingredient, wherein the patient is a patient with inadequate efficacies of latanoprost such that, when subjected to treatment with latanoprost, a) a width of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 4.5 mmHg or less, or b) a rate of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 18% or less.

2. The method according to claim 1 , wherein the treatment of glaucoma or ocular hypertension includes treating glaucoma or ocular hypertension with latanoprost and then further treating glaucoma or ocular hypertension by lowering intraocular pressure with the active ingredient.

3. The method according to claim 1 , wherein a content of the omidenepag, the ester thereof, or the salt thereof in the pharmaceutical preparation is 0.001 to 0.003% (w/v).

4. The method according to claim 1 , wherein a content of the omidenepag, the ester thereof, or the salt thereof in the pharmaceutical preparation is 0.002% (w/v).

5. The method according to claim 1 , wherein the omidenepag, the ester thereof, or the salt thereof is omidenepag isopropyl.

6. The method according to claim 1 , wherein the administration is ophthalmic administration.

7. A method of treating glaucoma or ocular hypertension, comprising: administering to a patient a pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof as an active ingredient, wherein the glaucoma is glaucoma resistant to treatment of glaucoma with latanoprost, and the ocular hypertension is ocular hypertension resistant to treatment of ocular hypertension with latanoprost such that, when subjected to treatment with latanoprost, a) a width of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 4.5 mmHg or less, or b) a rate of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 18% or less.

8. A method of treating glaucoma or ocular hypertension including administering to a patient a pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof as an active ingredient, the method comprising the following steps:
(1) a first treatment step of administering to a patient latanoprost, or a salt thereof;
(2) a step of judging whether the first treatment step is inadequate in treatment such that, a) a width of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure in the first treatment is 4.5 mmHg or less, or b) a rate of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 18% or less; and
(3) a second treatment step of further administering to a patient a pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof as an active ingredient when the first treatment step is inadequate in terms of a) or b) of the step (2).

9. A method of treating glaucoma or ocular hypertension, comprising:
confirming that a patient is a patient with inadequate efficacies of latanoprost such that, when subjected to treatment with latanoprost, a) a width of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 4.5 mmHg or less, or b) a rate of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 18% or less, and then
administering to the patient a pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof as an active ingredient.

10. A method of treating glaucoma or ocular hypertension, comprising:
confirming that the glaucoma is glaucoma resistant to treatment of glaucoma with latanoprost, and that the ocular hypertension is ocular hypertension resistant to treatment of latanoprost, such that, when subjected to treatment with latanoprost, a) a width of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 4.5 mmHg or less, or b) a rate of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure is 18% or less, and then
administering to a patient a pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof as an active ingredient.

Assignees

• Santen Pharmaceutical Co Ltd

Inventors

• KAWATA Hisashi
• Kawabata Noriko
• Shams Naveed

Classifications

• A61K31/5575

  having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title

• A61P27/06

  Antiglaucoma agents or miotics · CPC title

• A61P27/00

  Drugs for disorders of the senses · CPC title

• A61K9/0051

  Ocular inserts or implants · CPC title