InSite Vision Announces Positive Top-Line Safety Results from Phase 1 AzaSite Plus Clinical Study
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- Published on Wednesday, 14 February 2007 02:00
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ALAMEDA, CA, USA | Feb 13, 2007 | InSite Vision Incorporated (AMEX:ISV) -- an ophthalmic therapeutics, diagnostics and drug delivery company, is pleased to announce the top-line results from the Phase 1 (safety) clinical study of AzaSite Plus (ISV-502), a combination antibiotic/corticosteroid product formulated in DuraSite(R).
The Phase 1 clinical study was intended to evaluate both the safety and tolerability of the AzaSite Plus formulation in normal volunteers. The trial enrolled 46 subjects with ages ranging from 19 to 67 years. Trial participants received eye drops of either placebo or AzaSite Plus two times daily for 14 days. Demographic characteristics were evenly distributed across treatment groups.
Preliminary safety data showed that AzaSite Plus was well tolerated. No serious adverse events were reported. Treatment-related ocular adverse events were minimal in frequency and equivalent between the two groups. There were no significant differences in intraocular pressure between the AzaSite Plus group and placebo group after 14 days of treatment.
Kumar S. Chandrasekaran, Ph.D., President and CEO stated, "The positive results from the AzaSite Plus Phase 1 clinical trial establish the foundation for clinical efficacy testing of the formulation. We will work very diligently with the FDA to move this product through the regulatory process."
AzaSite Plus, the next product in the AzaSite product franchise, combines azithromycin and dexamethasone in DuraSite which is InSite Vision's drug delivery system for topical ophthalmic indications. It provides the broad anti-bacterial coverage of InSite Vision's AzaSite product (for which an NDA has been filed). AzaSite Plus will be indicated for ophthalmic conditions, such as blepharitis, in which simultaneous antimicrobial and anti-inflammatory treatments are required. Both AzaSite and AzaSite Plus achieve high tissue levels of drug with reduced dosing frequency when compared with currently available forms of treatment.
About InSite Vision Incorporated
InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma 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 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, InSite Vision currently expects AzaSite to be commercially launched in the United States, 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 gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into InSite Vision'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.
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 NDA for AzaSite, the commercialization of the Company's AzaSite product, the Company's plans for further clinical testing of AzaSite Plus and the FDA approval process for AzaSite Plus. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain substantial additional immediate funding to continue its operations; the results of InSite Vision's clinical trials and FDA review and approval of same; 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; determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205 as described in detail in and including the other risks described in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 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.
CONTACT: Ashton Partners
Barry Hutton, 888-857-7839 (Investor Contact)
SOURCE: InSite Vision Incorporated