BUSINESS WIRE
Top-Line Results Anticipated to be Available in the First Half of 2011
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB:INSV), a company developing novel
ophthalmic therapeutics, today announced that patient enrollment was
recently completed in the company’s Phase 1/2 clinical trial of ISV-303,
a novel compound being developed to reduce the pain and inflammation
associated with ocular surgery. ISV-303 combines a low dose of the
non-steroidal anti-inflammatory (NSAID) bromfenac (BROMDAY™/Xibrom™
marketed by ISTA Pharmaceuticals) with InSite Vision’s proprietary
DuraSite® technology.
InSite Vision commenced the Phase 1/2 clinical trial in August and
enrolled approximately 160 eligible patients undergoing cataract
surgery. The study is designed to evaluate the safety and efficacy of
ISV-303 when administered either once or twice daily. Patients were
randomized into one of four study arms examining ISV-303 as compared to
the commercial bromfenac (once or twice daily) or vehicle (e.g.,
DuraSite). Patient dosing and follow-up for the Phase 1/2 clinical trial
is expected to be completed during January, and InSite anticipates
announcing top-line results in the first half of 2011. Data from this
study are expected to provide guidance on the design of a Phase 3
clinical program. InSite Vision anticipates an additional Phase 2
clinical trial for ISV-303 to investigate, among other things, the
pharmacokinetics of ISV-303 in humans.
“We are very pleased by our team’s performance on the accelerated rate
of enrollment of this Phase 1/2 clinical trial, which was one of the
fastest rates on record for a trial of this size and design,” said
Timothy Ruane, Chief Executive Officer of InSite Vision. “We believe the
combination of our DuraSite technology with the approved NSAID bromfenac
may create a superior new therapy to improve the outcome of patients
undergoing ocular surgery. With an improved efficacy and safety profile,
and patent protection extending into 2029, we believe ISV-303 is well
positioned to compete in the expanding $300 million ophthalmic NSAID
U.S. market.”
Based on promising head-to-head preclinical results evaluating ISV-303
versus commercially-available bromfenac, in both single- and multi-use
settings, InSite Vision believes ISV-303 has the potential to offer
improved efficacy and safety advantages. These head-to-head data have
been accepted for publication in a prominent peer-reviewed journal, with
publication anticipated in the first quarter of 2011.
Cataract surgery is the most frequently performed ocular surgery in the
United States, with more than three million procedures annually.
Following surgery, anti-inflammatory eye drops are typically prescribed
to reduce pain and inflammation and enhance healing.
ISV-303 is designed to extend the duration of drug residence on the
surface of the eye to facilitate better penetration, while potentially
improving the efficacy and safety profile, particularly for the
prevention of cystoid macular edema. ISV-303 combines a low
concentration of bromfenac with DuraSite, InSite Vision’s proven
bioadhesive polymer technology. In preclinical studies, ISV-303
demonstrated a superior delivery and ocular distribution profile when
compared to the commercially-available bromfenac eye drop. Further,
ISV-303’s improved distribution profile was consistent across all ocular
tissues, including both the front and back of the eye. InSite Vision is
initially developing ISV-303 for use in a post-operative setting to
suppress or reduce inflammation and eye pain.
About InSite Vision
InSite Vision is committed to advancing new and superior ophthalmologic
products for unmet eye care needs. The company’s product portfolio
utilizes InSite Vision’s proven DuraSite® bioadhesive polymer core
technology, an innovative platform that extends the duration of drug
retention on the surface of the eye, 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%, marketed in the U.S. by Inspire
Pharmaceuticals, and Besivance™ (besifloxacin ophthalmic suspension)
0.6%, marketed by Bausch & Lomb and their partner Pfizer Inc. InSite
Vision’s clinical-stage ophthalmic product pipeline includes ISV-502 and
ISV-305 for the treatment of eye infections, and ISV-303 for pain and
swelling associated with ocular surgery. 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 complete
Phase 1/2 clinical trial for ISV-303 and the timing thereof and for
announcing results thereof, expected indications for, and potential
advantages of, ISV-303, the potential market size for ISV-303, the
expected benefits of ISV-303 and plans for a subsequent Phase 2 and 3
trials for ISV-303. Such statements entail a number of risks and
uncertainties, including but not limited to: the results of clinical
trials for ISV-303; the timing of completion of the Phase 1/2 clinical
trial, InSite’s ability to obtain Food and Drug Administration (FDA)
approval to commence additional 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.
BROMDAY™/Xibrom™ (bromfenac ophthalmic solution) 0.09%, is a trademark
of ISTA Pharmaceuticals.
BESIVANCE™ is a trademark of Bausch & Lomb Incorporated.