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InSite Vision Completes Enrollment In First Phase 3 AzaSite(TM) Clinical Study

Posted on: Thursday, 29 September 2005, 18:01 CDT

InSite Vision Incorporated (AMEX:ISV) -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced the completion of enrollment for one of its two Phase 3 clinical studies with AzaSite(TM) for the treatment of bacterial conjunctivitis. The Phase 3 clinical study was a randomized, double blind, active-controlled study evaluating the safety and efficacy of AzaSite in patients with bacterial conjunctivitis. The randomized patients were treated for five days with either AzaSite or tobramycin ophthalmic solution. The goal of the study was to show equivalent efficacy between AzaSite and tobramycin-treated patients.

Preliminary results based on patients who have completed the study from the combined AzaSite and tobramycin groups indicate that both ophthalmic solutions were well tolerated by the patients. There were no drug-related serious adverse events.

There are a total of 69 study sites involved in the study; 58 in America, and 11 in 3 Latin American countries. Of all the patients enrolled, approximately 59% were pediatric patients with ages between 1 to 17 years old and the remaining patients were adults. A wide variety of bacteria was encountered in the trial, including both Gram positive organisms such as Streptococcus pneumoniae and Gram negative organisms such as Haemophilus influenzae.

Over the next several weeks, all of the data from the study sites will be collected, entered, verified and the database locked. Close-out visits will occur for each site according to Good Clinical Practices (GCP). Then the formal statistical analysis of the data will begin, and unblinded efficacy results are anticipated in six to eight weeks.

AzaSite contains 1% azithromycin, a broad spectrum antibiotic formulated with DuraSite(R), InSite Vision's patented drug-delivery vehicle, which offers the benefit of a less frequent dosing regimen. If approved, it is anticipated that AzaSite will become the first ocular antibiotic with a once daily dosing regimen after an initial loading dose, which may increase patient compliance and therapeutic efficacy.

About InSite Vision Incorporated

InSite Vision Incorporated's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a less frequent, low-dosing regimen, attractive to both the eye-care patient and physician. The Company intends to expand this "technology platform" to include additional indications and product options for the worldwide market.

In the glaucoma area, the Company has continued to focus genomic research on the TIGR 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 (mt-1) in the promoter region of the glaucoma-related TIGR gene.

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 timing of initiation and completion of current and future clinical trials, the timing of availability of results for completed studies, the success thereof, the potential benefits and commercialization of AzaSite, and the timing and success thereof. Such statements entail a number of risks and uncertainties, including but not limited to: 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, as amended, and its quarterly reports on Form 10-Q. Any projections in this press release and/or presentation 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 and/or presentation. Actual events or results could differ materially and one should not assume that the information provided in this release and/or presentation is still valid at any later date.

Note to Editors: OcuGene 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.

Source: Business Wire

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