Healthcare Industry News: Tobramycin
News Release - August 3, 2006
InSite Vision to Present Results From Second of Two Pivotal Phase 3 Clinical TrialsALAMEDA, Calif.--(HSMN NewsFeed)--Aug. 3, 2006--InSite Vision Incorporated (AMEX:ISV ), an ophthalmic company focused on ocular infections, glaucoma and retinal diseases, announced today the acceptance of two abstracts related to its second pivotal trial of the topical eye drop antibiotic, AzaSite (1% azithromycin in DuraSiteŽ). The vehicle-controlled, prospective, multi-center, bacterial conjunctivitis trial showed AzaSite was superior to the vehicle in both clinical resolution of the signs and symptoms of bacterial conjunctivitis as well as bacterial eradication. The efficacy and safety data will be presented at the upcoming meeting of the American Academy of Ophthalmology in Las Vegas, Nevada to be held November 11 - 14, 2006. The presentation schedule is as follows:
- Efficacy of Azithromycin 1% Eye Drops vs. Vehicle as First-Line Therapy for Bacterial Conjunctivitis, Mark Abelson, MD, Warren Heller, MD, and the AzaSite Clinical Study Group.
- Safety and Tolerability of 1% Azithromycin Eye Drops as Anti-infective Therapy for Bacterial Conjunctivitis, Warren Heller, MD, Mark Abelson, MD, and the AzaSite Clinical Study Group.
The first phase 3 study was a double-blinded, prospective, active-controlled bacterial conjunctivitis trial. It showed AzaSite dosed twice daily for the first 2 days and once daily for 3 more days was equivalent to Tobramycin dosed four times daily for 5 days in resolving clinical signs and symptoms of bacterial conjunctivitis and eradicating offending bacteria. The second phase 3 study was a double-blinded, prospective, vehicle-controlled trial. It showed AzaSite was superior to the vehicle in both clinical resolution of the signs and symptoms of bacterial conjunctivitis and bacterial eradication. Both trials revealed a superior safety profile of AzaSite.
Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "These clinical trial results support AzaSite's value proposition of established efficacy and coverage with the convenience and compliance of a once-a-day dosing regimen."
About InSite Vision Incorporated
InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. The Company'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 filing and approval of an NDA with the FDA, the Company 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, the Company 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 the Company'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 anticipated closing of the private placement and the proposed use of proceeds therefrom. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain additional financing in the near future, InSite Vision's ability to enroll and complete future clinical trials for AzaSite; the results of InSite Vision's clinical trials, particularly for AzaSite; the ability to 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; 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. 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 and its quarterly reports on Form 10-Q, under the caption "Risk Factors". Any projections in this press release 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 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
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