Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders

A technology for presbyopia and eyes, which is applied in drug combinations, sensory diseases, muscular system diseases, etc. It can solve patients' discomfort, burning sensation, red eyes and other problems, and achieve the effect of improving visual performance and reducing pupil size

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

REV-EYES TM Some of the disadvantages are that it has been reported to cause a marked burning sensation after application, which makes patients uncomfortable, as well as noticeable redness of the eyes

Method used

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  • Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders
  • Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders
  • Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0413] Example 1 - Phentolamine mesylate in the treatment of presbyopia in human subjects

[0414] The therapeutic ability of phentolamine mesylate on human subjects with presbyopia can be evaluated based on clinical studies in which ophthalmic solutions containing phentolamine mesylate are administered to the eyes of patients, The patient is then assessed for improvement in visual performance, including near vision. The experimental procedure and results are described as follows

[0415] Part I - Experimental Procedures

[0416] Human subjects were screened for potential subjects and included in the study if eligible. Exemplary inclusion and exclusion criteria for this study are listed below. If a subject does not meet the inclusion / exclusion criteria, but the investigator believes that the subject should be included in the study, deviations can be tracked after discussions between the Principal Investigator and the study sponsor.

[0417] Inclusion criteria

[0418]...

Embodiment 2

[0436] Example 2 - Phentolamine mesylate in the treatment of presbyopia in human subjects

[0437] The therapeutic ability of phentolamine mesylate on human subjects with presbyopia can be evaluated based on clinical studies in which ophthalmic solutions containing phentolamine mesylate are administered to the eyes of patients, The patient is then assessed for improvement in visual performance, including near vision. The experimental procedure and results are described below.

[0438] Part I - Experimental Procedures

[0439] Human subjects were screened for potential subjects and included in the study if eligible. Exemplary inclusion and exclusion criteria for this study are listed below. If a subject does not meet the inclusion / exclusion criteria, but the investigator believes that the subject should be included in the study, deviations can be tracked after discussions between the Principal Investigator and the study sponsor.

[0440] Inclusion criteria

[0441] · A...

Embodiment 3

[0473] Example 3 - Reversal of mydriasis in human subjects with phentolamine mesylate

[0474] The ability of phentolamine mesylate to reverse pharmacologically induced mydriasis in the eyes of normal healthy human subjects was evaluated in a randomized, crossover, double-blind, placebo-controlled clinical study. Approximately 32 subjects were recruited and randomized 1:1 to one of two treatment sequences. All subjects were first administered a mydriatic (phenylephrine (2.5% w / w) or tropicamide (1% w / w) )). Then, approximately one hour after receiving the mydriatic, subjects were administered study drug according to Treatment Plan 1 or Treatment Plan 2.

[0475] In Treatment 1, subjects received placebo on the first treatment day (Visit 1 / Day 1) and 1 on the second treatment day (Visit 2 / Day 8+2). % w / w Phentolamine Mesylate Ophthalmic Solution. In treatment regimen 2, subjects received 1% w / w phentolamine mesylate ophthalmic solution on the first treatment day (Visit 1 / ...

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Abstract

The invention provides methods, compositions, and kits containing an alpha-adrenergic antagonist, such as phentol amine, for use in mono-therapy or as part of a combination therapy to treat patients suffering from presbyopia, mydriasis, and/or other ocular disorders.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 62 / 751,391, filed October 26, 2018; the entire contents of which are hereby incorporated by reference. [0003] field of invention [0004] The present invention provides methods, compositions and kits comprising an alpha-adrenergic antagonist, such as phentolamine, for use in monotherapy or as part of a combination therapy for the treatment of patients with presbyopia, mydriasis and / or other Patients with eye diseases. Background technique [0005] Presbyopia is an eye disease related to aging that results in the inability to focus on nearby objects. Presbyopia is usually caused by hardening of the eye's lens, which reduces its ability to flex. People usually first notice the effects of presbyopia around the age of 40, and the effects become more pronounced over the ensuing two decades. The effects of presbyopia can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/417A61P21/08A61P27/06
CPCA61K31/417A61K31/4164A61P27/08A61P27/10A61K9/0048A61K2300/00A61P27/06A61K45/06A61K31/4178A61K31/498A61K47/12A61K47/26A61K9/08A61K31/138A61K31/496A61K31/517A61K31/18A61K31/4045A61K31/55A61K31/4745A61K31/222A61K31/439A61K31/4025A61K31/221A61K31/341A61K31/557A61K31/5575A61K31/27A61K31/407A61K31/661A61K47/10A61P27/02
Inventor W·H·皮特里克A·R·梅尔M·苏伊K·查里扎尼斯B·霍夫曼
Owner OCUPHIRE PHARM INC
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