Message #19 From:
NewsBot Date: November 8, 2006 04:00:00 AM
ISV News InSite Vision Announces Initiation of a Phase 1 Safety Trial on AzaSite Plus(TM)
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (AMEX:ISV) -- an ophthalmic therapeutics,
diagnostics and drug delivery company, is pleased to announce that a
Phase 1 (safety) clinical study for AzaSite Plus (ISV-502), a
combination antibiotic/corticosteroid, has been initiated. 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.
AzaSite Plus provides the broad bacteria coverage of InSite Vision’s
AzaSite product (for which an NDA has been filed), featuring reduced
dosing and drug safety, while the addition of dexamethasone provides a
proven steroid for the treatment of ocular inflammation. The product
would be indicated for ocular treatment where inflammation and bacterial
infection are present, typically represented in conditions such as
blepharitis. The Phase 1 clinical study is intended to evaluate both the
safety and tolerability of the AzaSite Plus formulation in normal
volunteers.
Kumar S. Chandrasekaran, Ph.D., President and CEO stated, “The
AzaSite Plus Phase 1 clinical trial is an important milestone for InSite
Vision, as we initiate the clinical testing of the next product in the
AzaSite product franchise. We expect this product to expand the overall
market for our AzaSite franchise to other significant indications, based
on the demonstrated efficacy and convenience of our AzaSite product.”
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 in early 2007,
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 the 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.
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 AzaSite NDA, the anticipated
commercialization of AzaSite and other product candidates, and the
Company’s product development plans including
the status and intended results of the AzaSite Plus Phase 1 clinical
trial and market opportunities for InSite Vision’s
products.Such statements entail a number of risks and
uncertainties, including but not limited to:InSite Vision’s
ability to obtain substantial additional funding to continue its
operations;the results of InSite Vision's clinical trials for
AzaSite Plus and other product candidates; 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
and determinations by the FDA, including those with respect to OcuGene,
AzaSite and ISV-205. Reference is made to the discussion of these and
other 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”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.
