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Tear substitutes

A technique for dry eyes and ophthalmic preparations, applied in the field of compositions containing recombinant mucin

Inactive Publication Date: 2014-01-08
RECOPHARMA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, successful lens wear may require tear substitutes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment I

[0152] Standard molecular biology methods known in the art, not specifically described herein, generally follow substantially the following references: Sambrook et al., Molecular cloning: A laboratory manual, Cold Springs Harbor Laboratory, New-York (1989, 1992), and Ausubel et al., Current Protocols in Molecular Biology, John Wiley and Sons, Baltimore, Md. (1988), and Ausubel et al., Current Protocols in Molecular Biology, John Wiley and Sons, Baltimore, Md. (1989), and Perbal , A Practical Guide to Molecular Cloning, John Wiley & Sons, New York (1988), and Watson et al., Recombinant DNA, Scientific American Books, New York, and Birren et al. (Ed.) Genome Analysis: A Laboratory Manual Series, Volumes 1-4 Cold Spring Harbor Laboratory Press, New York (1998), and the methods set forth in US Patent Nos. 4,666,828, 4,683,202, 4,801,531, 5,192,659, and 5,272,057, incorporated herein by reference. Polymerase chain reaction (PCR) was performed as in a standard PCR protocol: A Guide ...

Embodiment II

[0156] A rabbit model of reversal of dry eye onset.

[0157] Dry eye was established in rabbits by surgically closing the lacrimal excretory duct and rabbits were left untreated for at least 4 weeks. See Gilbard, J.P., 1996, "Dry Eye: phramcological approaches, effects, and progress," CLAO J. 22, 141-145. After confirmation of dry eye by Schirmer's test and ocular surface staining, the formulation of the present invention was instilled as a solution of 0.01, 0.1, 1.0%, 5% or 10% concentration in a neutral isotonic buffered aqueous solution. The formulation is applied to the surface of the eye in one drop of 50 microliters, up to 1-5 times per day, per day for 2-10 weeks. Dry eye symptoms are monitored weekly for 2-10 weeks, and an increase in the Schirmer score and / or a decrease in the amount of eye surface staining is indicative of the efficacy of the formulation of the invention in the treatment of dry eye disease.

Embodiment III

[0159] Vehicle Formulations and Exemplary Eye Drop Formulations.

[0160]Aqueous eye drop formulations optionally contain various additives commonly incorporated, such as buffers (e.g., phosphate buffers, borate buffers, citrate buffers, tartrate buffers, acetate buffers , amino acids, sodium acetate, sodium citrate, etc.), isotonic agents (for example, sugars such as sorbitol, dextrose, and mannitol, polyalcohols such as glycerin, concentrated glycerin, polyethylene glycol, and propylene glycol, salts such as sodium chloride), preservatives agents or disinfectants (for example, benzalkonium chloride, benzethonium chloride, p-hydroxybenzoates such as methyl p-hydroxybenzoate or ethyl p-hydroxybenzoate, benzyl alcohol, phenylethyl alcohol, sorbic acid, or its salts, thimerosal, chlorobutanol, etc.), dissolution aids or stabilizers (for example, cyclodextrins and their derivatives, water-soluble polymers such as polyvinylpyrrolidone), surfactants such as polysorbate 80 ( Tween ...

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PUM

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Abstract

The invention features ophthalmic formulations of mucin polypeptides to treat or prevent dry eye.

Description

[0001] related application [0002] This patent application claims priority to US Provisional Application No. 61 / 425,524, filed December 21, 2010, the contents of which are incorporated herein by reference in their entirety. technical field [0003] The present invention generally relates to compositions containing recombinant mucin useful as tear substitutes for the treatment of dry eye. Background technique [0004] The tear film is an aqueous solution containing electrolytes and proteins (the 4 main proteins are: lysozyme, lactoferrin, lipocalin, and secretory IgA) and has meibomian gland-derived Lipid layer (1). A very important protein component of tears is a group of proteins called mucins. They are known to be secreted (MUC2, 5AC, 5B, 6, 7, 9) or membrane associated (MUC1, 3A, 3B, 4, 16). Among the former, MUC5AC has been identified in tear fluid (2), and mRNAs for MUC5AC, 5B, 6 and 7 were detected in lacrimal gland tissue, but MUC2 was not (3). Membrane-associate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/17A61P27/04
CPCA61K38/17A61P27/02A61P27/04
Inventor J.霍尔格松A.尼尔松N.查茨萨维多T.约翰松
Owner RECOPHARMA AB
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