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InSite Vision Announces Initiation of a Phase 1 Safety Trial on AzaSite Plus(TM).


ALAMEDA, Calif. -- InSite Vision Incorporated (AMEX AMEX

See: American Stock Exchange
:ISV (Independent Software Vendor) A person or company that develops software. It implies an organization that specializes in software only and is not part of a computer systems or hardware manufacturer. ) -- an ophthalmic therapeutics, diagnostics and drug delivery company, is pleased to announce that a Phase 1 (safety) clinical study for AzaSite Plus (ISV-502), a combination antibiotic/corticosteroid, has been initiated. AzaSite Plus, the next product in the AzaSite product franchise, combines azithromycin and dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the  in DuraSite which is InSite Vision's drug delivery system for topical ophthalmic indications.

AzaSite Plus provides the broad bacteria coverage of InSite Vision's AzaSite product (for which an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  has been filed), featuring reduced dosing and drug safety, while the addition of dexamethasone provides a proven steroid for the treatment of ocular inflammation. The product would be indicated for ocular treatment where inflammation and bacterial infection are present, typically represented in conditions such as blepharitis blepharitis /bleph·a·ri·tis/ (blef?ah-ri´tis) inflammation of the eyelids.

blepharitis angula´ris  inflammation involving the angles of the eyelids.
. The Phase 1 clinical study is intended to evaluate both the safety and tolerability of the AzaSite Plus formulation in normal volunteers.

Kumar S. Chandrasekaran, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  stated, "The AzaSite Plus Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study.  is an important milestone for InSite Vision, as we initiate the clinical testing of the next product in the AzaSite product franchise. We expect this product to expand the overall market for our AzaSite franchise to other significant indications, based on the demonstrated efficacy and convenience of our AzaSite product."

About InSite Vision Incorporated

InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball).  and retinal diseases. InSite Vision's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic The term broad-spectrum antibiotic refers to an antibiotic with activity against a wide range of disease-causing bacteria. This is in contrast to a narrow-spectrum antibiotic which is effective against only specific families of bacteria.  formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the approval of its NDA with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
, InSite Vision currently expects AzaSite to be commercially launched in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  in early 2007, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.

In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR TIGR The Institute for Genomic Research
TIGR Treasury Investment Growth Receipt
TIGR This Is Getting Ridiculous
TIGR Thermally Induced Gallium Removal
TIGR TSPI Interface for GPS/RAJPO
 gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into the InSite Vision's commercially available OcuGene(R) glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker genetic marker
n.
A gene phenotypically associated with a particular, easily identified trait and used to identify an individual or cell carrying that gene.
 (mt-1) in the promoter region of the glaucoma-related TIGR gene.

Additional information can be found at our website, www.insitevision.com.

This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the Company's ability to obtain FDA approval of its AzaSite NDA, the anticipated commercialization of AzaSite and other product candidates, and the Company's product development plans including the status and intended results of the AzaSite Plus Phase 1 clinical trial and market opportunities for InSite Vision's products. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain substantial additional funding to continue its operations; the results of InSite Vision's clinical trials for AzaSite Plus and other product candidates; the ability to obtain FDA approval of its AzaSite NDA from the FDA for the commercialization of AzaSite and its other product candidates; the ability of InSite Vision to enter into a corporate collaboration for its AzaSite and other product candidates; the ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to expand its technology platform to include additional indications and patent options; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others and determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205. Reference is made to the discussion of these and other risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 and its quarterly reports on Form 10-Q Form 10-Q

See 10-Q.
, under the caption "Risk Factors" and elsewhere in such reports. Any forward looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.

Note to Editors: OcuGene(R) is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite(R) and OcuGene(R) are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Nov 8, 2006
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