Therapeutic agent for dry eye syndrome accompanied by Sjogren's syndrome

A technology for Sjögren's syndrome and dry eye syndrome, applied in drug combinations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as non-recognition, susceptibility to infection, and increased intraocular pressure, and achieve the goal of improving epithelial damage Effect

Active Publication Date: 2021-05-25
TEIKA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to side effects such as increased intraocular pressure or susceptibility to infection, care must be taken when using steroid eye drops for a long period of time
In addition, cyclosporin, an immunosuppressant, is the only dry eye prescription drug in the United States, but some countries do not approve its use as a dry eye treatment drug

Method used

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  • Therapeutic agent for dry eye syndrome accompanied by Sjogren's syndrome
  • Therapeutic agent for dry eye syndrome accompanied by Sjogren's syndrome
  • Therapeutic agent for dry eye syndrome accompanied by Sjogren's syndrome

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Improvement effect on MRL / Lpr mice (Sjogren's syndrome model mice)

[0046] 1. Test method

[0047] 18-week-old MRL / Lpr mice (Jabs DAPrendergast RA. Murine models of Sjogren's syndrome. Adv Exp Med Biol. 1994, 350, p. 623-30) known as a model animal of Sjogren's syndrome, Both eyes were administered 1% (w / v) sodium ozagrel eye drops or citric acid buffer solution as a control, 4 times a day (3 hours interval) with 5 μL per eye, for 14 days (13-14 days in each group). example). In addition, mice from the Institute of Cancer Research (ICR, Institute of Cancer Research) were used as a normal group (Normal) (15 cases), and citrate buffer was similarly administered to the normal group by eye drops. On the day after the last eyedrop administration, 1 μL of 1% Lissamine Green solution was instilled in both eyes under pentobarbital anesthesia, and the degree of damage to the cornea and conjunctiva was scored. Regarding the corneal damage score, the case where punctate staini...

Embodiment 2

[0051] Improvement effect on dry eye patients with Sjogren's syndrome

[0052] 1. Test method

[0053] For 65 patients with dry eye syndrome accompanied by Sjogren's syndrome, placebo (21 cases), or 1% (w / v) (22 cases) or 0.5% was repeatedly administered to both eyes with 1 drop once, 4 times a day (w / v) (22 cases) of sodium ozagrel eye drops for 8 weeks.

[0054] It should be noted that the results of this test were carried out on patients with dry eye syndrome, referring to the conditions of the revised diagnostic criteria for Sjogren's syndrome (1999) of the Research Group of the Ministry of Health, Labor and Welfare of Japan, and extracting dry eye with Sjogren's syndrome obtained from the analysis of patients with the disease.

[0055] 2. Evaluation items

[0056] The total score of lissamine green conjunctival staining (the damage degree of the 6 regions is scored on a scale of 0 to 3 points), the total score of the fluorescein corneal staining degree (the damage degr...

Embodiment 3

[0061] Study on usage and dosage of dry eye syndrome accompanied by Sjogren's syndrome

[0062] 1. Analysis method

[0063] In the results of the following clinical trials A and B for dry eye patients, dry eye patients with Sjögren's syndrome were extracted on the same basis as in Example 2. The effects of placebo (10 cases), or 1% (w / v) (7 cases) or 2% (w / v) (13 cases) of Ozagrel sodium eye drops on those associated with Sjogren's syndrome The effect of dry eye patients was analyzed.

[0064] 2. Test content

[0065] Clinical Trial A:

[0066] For patients with dry eye syndrome, placebo, or 0.5% (w / v), 1% (w / v) or 2% (w / v) is repeatedly administered to both eyes with 1 drop once, 4 times a day The concentration of ozagrel sodium eye drops for 4 weeks.

[0067] Clinical Trial B:

[0068] For patients with dry eye syndrome, placebo or ozagrel sodium drops at a concentration of 1% (w / v) or 2% (w / v) were repeatedly administered to both eyes 1 drop at a time, 4 times a day ...

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Abstract

The present invention relates to a pharmaceutical composition for treating dry eye associated with Sjögren's syndrome, containing Ozagrel or a pharmacologically acceptable salt thereof as an active ingredient. The pharmaceutical composition of the present invention plays an important role in the treatment of corneal and conjunctival epithelial injuries associated with dry eye syndrome of Sjögren's syndrome, which still tends to remain strongly after dripping general dry eye syndrome therapeutic drugs (such as artificial tears, etc.). Especially excellent therapeutic effect. Therefore, the pharmaceutical composition of the present invention is useful as a therapeutic pharmaceutical composition for dry eye syndrome accompanied by Sjogren's syndrome.

Description

technical field [0001] The present invention relates to a pharmaceutical composition useful for the treatment of dry eye associated with Sjogren's syndrome. [0002] More specifically, the present invention relates to a pharmaceutical composition useful for the treatment of dry eye associated with Sjögren's syndrome, comprising ozagrel or a pharmacologically acceptable salt thereof as an active ingredient. Background technique [0003] In recent years, with the popularization of air conditioners and the increase of visual display terminal (VDT, visual display terminals) workers, etc., the number of patients with dry eye syndrome has increased rapidly. Therefore, the importance of dry eye treatment has increased (Non-Patent Document 1). [0004] Sjögren's syndrome is known as an autoimmune disease of unknown cause accompanied by dry eye. Since Sjögren's syndrome is accompanied by a high degree of lymphocyte infiltration in lacrimal glands, salivary glands, etc., dry eye ass...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4174A61K9/08A61P27/02A61P37/02
CPCA61K9/08A61K31/4174
Inventor 浅利哲也清野雄治青山晃敏吉田拓允
Owner TEIKA PHARMA CO LTD
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