BUSINESS WIRE
ISV-303 Leverages DuraSite® Technology to Improve Ocular Distribution
and Potential Activity
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV), a company developing
ophthalmic products for unmet eye care needs, today announced plans to
advance new development candidate ISV-303, a topical anti-inflammatory
product intended to reduce the pain and swelling associated with ocular
surgery. InSite Vision formulated a lower concentration of bromfenac
with its proprietary DuraSite® technology to create a proprietary
therapeutic product. InSite Vision intends to advance ISV-303 into
clinical studies pending the completion of Investigational New
Drug-enabling toxicology studies in the first half of 2010.
“ISV-303 uses a lower concentration of an approved product and combines
it with a commercially-proven technology to create a promising
therapeutic that we believe will offer significant safety, efficacy and
dosing advantages,” said Kamran Hosseini, M.D., Ph.D., Chief Medical
Officer and Vice President, Clinical Affairs. “Our DuraSite platform
offers a number of therapeutic advantages, as has been demonstrated in
two commercial products, AzaSite and Besivance, which leverage this
technology. In preclinical studies, ISV-303 appears to offer compelling
benefits that we hope will translate into an improved, easy-to-use eye
drop to alleviate the pain and swelling associated with cataract
surgery. We look forward to advancing this new development candidate
into clinical trials next year.”
Bromfenac (Xibrom™, marketed by ISTA Pharmaceuticals) is a topical
non-steroidal anti-inflammatory product approved in the U.S. for the
treatment of postoperative inflammation in patients who have undergone
cataract extraction. By combining a lower concentration of bromfenac
with DuraSite, InSite Vision’s proven bio-adhesive polymer technology,
ISV-303 is intended to extend the duration of drug residence on the
eye’s surface to facilitate better penetration and thus reduce dosing,
while potentially improving both efficacy and side effect profiles. In
preclinical studies to date, ISV-303 demonstrated a superior delivery
and ocular distribution profile when compared to the commercially
available product. Further, ISV-303’s improved distribution profile was
consistent across all ocular tissues, including both the front and back
of the eye. InSite Vision plans to present data from its preclinical
studies at an upcoming scientific meeting.
About DuraSite
InSite's DuraSite sustained delivery technology is a patented synthetic
polymer-based formulation designed to extend the residence time of a
drug relative to conventional topical therapies. It enables topical
delivery of a solution, gel or suspension and can be customized for
delivering a wide variety of potential drug candidates. The DuraSite
platform is currently leveraged in two commercial products for the
treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic
solution) 1% and Besivance™ (besifloxacin ophthalmic suspension) 0.6%.
InSite vision is also applying DuraSite to clinical- and
preclinical-stage product candidates to create a portfolio of novel
ophthalmic products.
About InSite Vision
InSite Vision is committed to advancing new and superior ophthalmologic
products for unmet eye care needs. InSite Vision is recognized for the
discovery and development of novel ocular pharmaceutical products based
on its DuraSite® bioadhesive polymer core technology, an innovative
platform that extends the duration of drug delivery on the eye’s
surface, thereby reducing frequency of treatment and improving the
efficacy of topically delivered drugs. The DuraSite platform is
currently leveraged in two commercial products for the treatment of
bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%
and Besivance™ (besifloxacin ophthalmic suspension) 0.6%. AzaSite is
approved in the United States and Canada and currently marketed by
InSite Vision’s partner, Inspire Pharmaceuticals in the United States.
InSite Vision has formed multiple strategic licensing and distribution
agreements with qualified partners to market AzaSite in select countries
in Asia and South America upon regulatory approval in those regions.
Besivance was approved by the U.S. Food and Drug Administration in the
second quarter 2009 and is being marketed by Bausch & Lomb and Pfizer
Inc.
InSite Vision’s ophthalmic product development pipeline also includes
ISV-502 and additional product candidates leveraging the company’s core
technologies. For further information on InSite Vision, please visit www.insitevision.com.
Forward Looking Statements
This news release contains certain statements of a forward looking
nature relating to future events, including, InSite's plans to advance
its ophthalmologic products, InSite’s plans to file an Investigational
New Drug application for ISV-303 and commence clinical trials and the
timing thereof, the expected indications and benefits of ISV-303, the
implication that AzaSite will be commercialized in various territories
outside the U.S. and Canada upon regulatory approval in those
territories, and InSite's corporate goals. Such statements entail a
number of risks and uncertainties, including but not limited to: the
results of any future clinical trials InSite may initiate, including
with respect to ISV-303; InSite’s ability to obtain Food and Drug
Administration (FDA) approval to commence clinical trials for ISV-303
and the timing thereof; InSite's reliance on third parties for the
commercialization of its products; the ability of InSite to enter into
corporate collaborations for its product candidates; InSite's ability to
expand its product platform to include additional indications; InSite's
ability to compete effectively, either alone or through its partners,
with other companies offering competing products or treatments; InSite's
ability to maintain and develop additional collaborations and commercial
agreements with corporate partners, including those with respect to
AzaSite; 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. 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.
AzaSite® and DuraSite® are registered trademarks of InSite Vision
Incorporated.
Xibrom™ (bromfenac ophthalmic solution) 0.09%, is a trademark of ISTA
Pharmaceuticals.
BESIVANCE™ is a trademark of Bausch & Lomb Incorporated.