InSite Vision to Hold Conference Call to Discuss Top Line Results of Pivotal Phase 3 Clinical Trial on November 30th.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, announced today that the Company will hold a conference call to discuss the top line results of one of its two pivotal phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. of AzaSite, azithromycin 1% solution in DuraSite(R), on Wednesday, November 30, 2005. S. Kumar Chandrasekaran, Ph.D., Chief Executive Officer, will host a conference call beginning at 10:30 a.m. Eastern Time on Wednesday, November 30, 2005 to discuss the top line results of the clinical trial and to answer questions. Individuals interested in listening to the conference call may do so by dialing (800) 475-3716 for domestic callers or (719) 457-2728 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (800) 203-1112 for domestic callers or (719) 457-0820 for international callers. All callers will have to enter the Replay Passcode: 2904045. The live conference call will also be available via the Internet on the investor relations Investor relations The process by which the corporation communicates with its investors. section of the Company's Web site at www.insitevision.com, and a recording of the call will be available for 90 days following the completion of the call. About InSite Vision InSite Vision is an ophthalmic company focused on 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. The Company's lead product is AzaSite(TM), which targets infections of the eye. AzaSite(TM) 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 successful results of Phase 3 clinical testing currently underway and filing and approval of a New Drug Application with the Food and Drug Administration, the Company currently expects to commercially launch AzaSite(TM) 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 2006, while seeking to expand this "technology platform" to include additional indications and product options for the worldwide market. In the glaucoma area, the Company 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 Company'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 the Company's website, www.insitevision.com. This news release contains, among other things, certain statements of a forward-looking nature relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc future events or the future business performance of InSite Vision, such as the timing of initiation and completion of current and future clinical trials, the success thereof the timing of the filing 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 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. , expected marketing plan for AzaSite, the potential benefits and commercialization of AzaSite, and the timing and success thereof, and the Company's plans to pursue expanding the AzaSite "technology platform." Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain immediate additional financing. InSite Vision's ability to enroll and complete future clinical trials for AzaSite; the results of InSite Vision's clinical trials, particularly for AzaSite; InSite Vision's ability to commence, complete and file an NDA with the U.S. FDA for AzaSite and its other product candidates, and receive approval from the FDA for the commercialization of AzaSite and its other product candidates; InSite Vision's 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; InSite Vision's ability to obtain additional financing when needed; 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 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. , as amended, and its quarterly reports on Form 10-Q Form 10-Q See 10-Q. . Any projections in this press release and/or conference call are based on the limited information currently available to InSite Vision, which is subject to change. Although any such 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 and/or conference call 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. |
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