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Methods and compositions for treatment of glaucoma and related conditions

A technology for glaucoma and disease, applied in the direction of drug combination, active ingredients of heterocyclic compounds, sensory diseases, etc., can solve problems such as lowering intraocular pressure, changing blood pressure, increasing intraocular pressure, etc.

Pending Publication Date: 2021-07-23
OCUPHIRE PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Id. However, not all α-adrenoceptor antagonists reduce IOP in patients
For example, the alpha-adrenoceptor antagonist dapirazole hydrochloride has been reported to not significantly alter intraocular pressure in normotensive or elevated intraocular pressure eyes

Method used

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  • Methods and compositions for treatment of glaucoma and related conditions
  • Methods and compositions for treatment of glaucoma and related conditions
  • Methods and compositions for treatment of glaucoma and related conditions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0394] Example 1 – Phentolamine mesylate reduces intraocular pressure in healthy human subjects with normal intraocular pressure

[0395] An aqueous solution containing phentolamine mesylate was administered as eye drops to the eyes of healthy persons with normal intraocular pressure, and the decrease in the intraocular pressure of the eyes was measured. The experimental procedure and results are described below.

[0396] Part I – Experimental Procedures

[0397] One of the test articles in Table 1 was administered in the form of eye drops to the eyes of healthy human subjects with normal intraocular pressure. The intraocular pressure in the eyes of the subjects was measured before the test article was applied and then again 2-3 hours after the test article was applied.

[0398] Table 1.

[0399] test product

describe

0.5%PM Phentolamine Mesylate 0.5% w / w in an aqueous vehicle 1% PM Phentolamine mesylate 1% w / w in aqueous vehicle pla...

Embodiment 2

[0407] Example 2 – Phentolamine mesylate reduces intraocular pressure in human subjects with an intraocular pressure of at least 22 mmHG

[0408] The ability of phentolamine mesylate to reduce intraocular pressure (IOP) in the eyes of human subjects with IOP ≥ 22 mmHg can be assessed based on clinical studies in which phentolamine mesylate containing Patients were then evaluated for the reduction in intraocular pressure in eyes receiving the aqueous ophthalmic solution containing phentolamine mesylate. The experimental procedure and results are described below.

[0409] Part I – Experimental Procedures

[0410] Human subjects are screened for potential enrollment and, if eligible, enrolled in the study. The inclusion and exclusion criteria of this study are as follows. If a subject does not meet the inclusion / exclusion criteria, but the investigator believes that the subject should be included in the study, deviations are allowed after discussions between the Principal In...

Embodiment 3

[0441] Example 3 - Phentolamine mesylate reduces intraocular pressure in human subjects with bilateral open-angle glaucoma or ocular hypertension

[0442] The ability of phentolamine mesylate to reduce intraocular pressure in the eyes of human subjects with bilateral open-angle glaucoma or ocular hypertension can be evaluated based on clinical studies in which phentolamine mesylate containing Aqueous ophthalmic solution of phentolamine mesylate was administered to patients, and then patients were evaluated for reduction in intraocular pressure in eyes receiving aqueous ophthalmic solution containing phentolamine mesylate. The experimental procedure and results are described below.

[0443] Part I – Experimental Procedures

[0444] Human subjects are screened for potential enrollment and, if eligible, enrolled in the study. The inclusion and exclusion criteria of this study are as follows.

[0445] Inclusion criteria

[0446] · Aged 18 years or older.

[0447] ·Diagnos...

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Abstract

Methods, compositions and kits comprising alpha-adrenergic antagonists, such as phentolamine, for the treatment of glaucoma, ocular hypertension, and / or other ocular disorders, such as non-arteritic anterior ischemic optic neuropathy or keratoconus, are provided. Said methods, compositions and kits may further comprise additional therapeutic agents, including prostaglandin analogues such as latanoprost, beta-adrenergic antagonists, alpha-adrenergic agonists, carbonic anhydrase inhibitors, cholinergic agonists, NMDA receptor antagonist, adenosine receptor antagonists, 5-HT2a receptor agonists, or Rho kinase inhibitors.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 62 / 745,806, filed October 15, 2018, and U.S. Provisional Patent Application Serial No. 62 / 752,088, filed October 29, 2018; which are hereby incorporated by reference The entire contents of each are incorporated herein. [0003] field of invention [0004] The present invention provides methods, compositions and kits comprising an alpha-adrenergic antagonist, such as phentolamine, for use in treating patients suffering from glaucoma, ocular hypertension and / or other ocular diseases. Background technique [0005] Glaucoma is an eye disease that usually affects the retina and / or optic nerve and, if left untreated, can lead to blindness. Various forms of glaucoma are described in the literature, such as congenital, open-angle, angle-closure, primary and secondary glaucoma. Prolonged elevated intraocular pressure is a common ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/417A61P27/06A61K31/5575A61P27/02
CPCA61K31/417A61K31/5575A61P27/02A61P27/06A61K2300/00A61K45/06A61K31/551A61K9/0048A61K47/12A61K47/26A61K9/08A61K31/138A61K31/222A61K31/27A61K31/382A61K31/4045A61K31/4164A61K31/4168A61K31/4178A61K31/439A61K31/444A61K31/4704A61K31/472A61K31/475A61K31/496A61K31/498A61K31/517A61K31/5377A61K31/55A61K31/558A61K31/683A61K31/7076
Inventor W·H·皮特里克A·R·梅尔M·苏施K·查里扎尼斯
Owner OCUPHIRE PHARM INC
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