InSite Vision Completes Enrollment In Second Phase 3 AzaSite(TM) Clinical Study
ALAMEDA, Calif., Jan. 13 /PRNewswire-FirstCall/ -- InSite Vision Incorporated -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced the completion of enrollment for the second of its two pivotal Phase 3 clinical studies with AzaSite(TM) for the treatment of bacterial conjunctivitis. This second Phase 3 clinical study was a randomized, double blind, vehicle-controlled study evaluating the safety and efficacy of AzaSite in patients with bacterial conjunctivitis. The randomized patients were treated for five days, twice daily for the first 2 days followed by once per day for days 3-5, with either AzaSite or a vehicle formulation. The goal of the study is to demonstrate superiority of AzaSite as compared to vehicle in clinical resolution of the eye infection, which is the primary efficacy endpoint.
There were a total of 58 sites involved in the study; 46 in the United States, and 12 in three Latin American countries. Of all the patients enrolled, approximately 34% 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 Staphylococcus Aureus 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 about eight weeks.
Positive top-line results from the first Phase 3 AzaSite clinical trial was released on November 30, 2005. Additional analysis on data from this first Phase 3 study indicate that AzaSite is also effective against azithromycin-resistant bacteria. Such efficacy is likely related to AzaSite providing extended ocular residence times due to its DuraSite formulation. This technology permits sufficient time for azithromycin to traverse cell membranes, achieve high tissue concentrations, and overcome efflux effects normally resident with resistant bacteria. The final results will be presented in an upcoming international ophthalmic conference.
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 is expected to increase patient compliance and therapeutic efficacy.
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 successful results of phase 3 clinical testing currently underway and filing and approval of an NDA with the FDA, the Company currently expects to commercially launch AzaSite 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 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 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 timing of initiation and completion of current and future clinical trials, the success thereof, the timing of the filing of an NDA with the FDA, 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, as amended, and its quarterly reports on Form 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.
CONTACT: InSite Vision Incorporated
S. Kumar Chandrasekaran/Sandra Heine, 510-865-8800http://www.newscom.com/cgi-bin/prnh/20060113/LAF015LOGOPRN Photo Desk, email@example.comInSite Vision Incorporated
CONTACT: S. Kumar Chandrasekaran or Sandra Heine, both of InSite VisionIncorporated, +1-510-865-8800
Web site: http://www.insitevision.com//