Treatment of ocular inflammatory diseases using laquinimod

a technology of ocular inflammatory diseases and laquinimod, which is applied in the direction of biocide, immunological disorders, drug compositions, etc., can solve problems such as permanent vision loss, and achieve the effect of high oral bioavailability

Inactive Publication Date: 2013-12-05
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]Disclosed is a method of treating ocular inflammatory disease (OID), including uveitis and conjunctivitis, using laquinimod or a pharmaceutically acceptable salt thereof. Laquinimod is a novel synthetic compound wi

Problems solved by technology

Inflammation from uveitis may result in a variety of other eye conditions, including glauco

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experimental examples

Example 1

Evaluation of Efficacy Following Daily Topical Administration of Laquinimod In S-Antigen-Induced Experimental Autoimmune Uveitis in Rats (EAU Model)

[0068]General.

[0069]A 1% (10 mg / ml) and a 5% (50 mg / ml) solution of laquinimod sodium were prepared in sterile water. Dissolution of laquinimod powder was achieved by shaking, stirring, or low-speed vortex. The solutions were stored for up to 2 weeks at 2-8° C. and up to 24 hours at room temperature. Laquinimod solutions were prepared under light protection and were protected from light for the duration of the experiment. Cyclosporine A was used as a reference material at a concentration of 25 mg / kg / j (Fluka). One 100 mg / 4 ml in olive oil dose was prepared every 2 days and stored at room temperature.

[0070]Animals and Animal Husbandry.

[0071]Thirty two (32) female albino Lewis rats, approximately 8 weeks old, were used for this study. All rats were held in observation for at least 3 days to monitor for signs of ill health or ocula...

example 2

Evaluation of Ocular Active Anaphylaxis Reduction Following Topical Ocular Administration Of Laquinimod in Mice (Late Phase) Using Ovalbumin Model

[0085]General.

[0086]Laquinimod solutions were prepared as in Example 1.

[0087]Animals and Animal Husbandry.

[0088]Forty (40) male Balb / c albino mice were used for this experiment. The mice were about 7-8 weeks old upon ordering, and were held in observation for at least three (3) days to monitor for signs of ill health or ocular abnormalities. Only healthy animals were accepted for use in this study. The rats were housed under identical environmental conditions, with a relative humidity of 55%±10%, continuous ventilation, and an automatic 12 hour light / dark cycle. Environmental conditions were continuously controlled and recorded. Animals had free access to food and water.

[0089]Materials and Methods.

[0090]Forty (40) Balb / c albino mice were randomly allocated to five groups of eight animals each. Only the right eyes of each animal were used i...

example 3

Dose Conversion Between Species

[0109]The National Institutes of Health (NIH) provides a table of Equivalent Surface Area Dosage Conversion Factors below (Table 8) which provides conversion factors that account for surface area to weight ratios between species.

TABLE 8Equivalent Surface Area Dosage Conversion FactorsToMouseMonkey20 gRat 150 g3 kgDog 8 kgMan 60 kgFROMMouse1½¼⅙  1 / 12Rat21½¼ 1 / 7Monkey421⅗⅓Dog641⅔1½Man127321

[0110]In the examples 4-9 below, the administration of the composition is once daily. The administration can be repeated daily for a period of one, two, three or four days, up to 14 days, or longer as necessary.

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Abstract

Disclosed is a method for treating an ocular inflammatory disease (OID), e.g., uveitis or conjunctivitis, comprising periodic administration of a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt thereof. Also provided is a pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof for use in treating a subject suffering from an OID, uveitis, bacterial conjunctivitis, viral conjunctivitis, an inflammation of the orbital tissue, the lacrimal apparatus, the eyelid, the cornea, the retina or the optic pathway. This application also provides a method for treating a subject suffering from an autoimmune disease-associated ocular inflammation comprising periodic ocular administration to the subject a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt, and an ocular pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof for use in treating an autoimmune disease-associated ocular inflammation.

Description

[0001]This application claims benefit of U.S. Provisional Application No. 61 / 655,526, filed Jun. 5, 2012, the entire content of which is hereby incorporated by reference herein.[0002]Throughout this application, various publications are referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains.BACKGROUND OF THE INVENTION[0003]Ocular Inflammatory Disease (“OID”) is a general term for describing inflammation affecting one or more parts of the eye or surrounding eye tissue. Uveitis is the inflammation of the uvea or the uveal tract, which includes the iris, the ciliary body and the choroid portions of the eye. Inflammation of the overlying retina, called retinitis, or of the optic nerve, called optic neuritis, may occur with or without accompanying uveitis. Anatomically, uveitis may be classified as anterior, intermediate, posterio...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/4704
CPCA61K9/0048A61K31/4704A61P27/02A61P27/14A61P29/00A61P37/06A61P37/08A61K9/0053A61K9/08
Inventor KAYE, JOELHALLAK, HUSSEINTARCIC, NORA
Owner TEVA PHARMA IND LTD
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