Healthcare Industry News: azithromycin
News Release - June 29, 2006
InSite Vision Announces Submission of AzaSite(TM) NDAALAMEDA, Calif.--(HSMN NewsFeed)--June 29, 2006--InSite Vision Incorporated (AMEX:ISV ) -- an ophthalmic products company currently developing therapies that treat ocular infection, glaucoma, and retinal diseases, today announced it has submitted to the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for AzaSite(TM) for the treatment of bacterial conjunctivitis. AzaSite combines a topical 1% azithromycin formulation with InSite's patented DuraSiteŽ ophthalmic drug-delivery system that increases ocular retention of the drug.
InSite Vision has completed the compilation and assembly of a hybrid electronic NDA filing in a modified Common Technical Document (CTD) format. This submission incorporates the positive results from the recently completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing and controls. InSite previously announced the completion of these two Phase 3 studies including a vehicle controlled study versus AzaSite and a study comparing 0.3% tobramycin versus AzaSite. The results of these trials showed that AzaSite was safe, well tolerated and efficacious in the treatment of bacterial conjunctivitis.
Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "The submission of the AzaSite NDA is a major milestone for InSite Vision and brings our lead product one very significant step further in the FDA approval process. We anticipate the launch of AzaSite in early 2007 as we pursue development of additional products that make up the AzaSite franchise."
Dr. Chandrasekaran added: "The fundamental characteristics of the AzaSite franchise remain strong and are enhanced by our significant progression announced today in our pursuit to reach commercialization for the product. Furthermore, our corporate partnership discussions are continuing as previously indicated. Our efforts in this matter are designed to ensure that we provide our product franchise with the most effective conduit to the various medical specialties, to maximize patient and physician acceptance, market opportunity and, importantly, shareholder value. Details of the finalized corporate relationships will be provided when available."
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 bacterial infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSiteŽ, InSite Vision's patented drug-delivery vehicle, offering the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the filing and approval of an 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 OcuGeneŽ 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 the Company's 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 expected timing of FDA approval of the AzaSite NDA, the Company's ability to obtain FDA approval of its NDA, and the anticipated date of commercialization of AzaSite. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain additional financing, InSite Vision's ability to commence, complete and file an NDA with the U.S. FDA for AzaSite, and receive approval from the FDA for the commercialization of AzaSite and the timing thereof; InSite Vision's ability to launch AzaSite and the timing of such a launch; 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; 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. Reference is made to the discussion under the caption "Risk Factors" and elsewhere 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. All forward-looking statements 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: OcuGeneŽ is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSiteŽ and OcuGeneŽ are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.
Source: InSite Vision
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.