ALAMEDA, Calif. – January 11, 2011 – InSite Vision Incorporated (OTCBB: INSV) today
announced that it has filed an Investigational New Drug (IND) application for ISV-101 with the
U.S. Food and Drug Administration (FDA). ISV-101 is InSite Vision's novel compound being
developed to treat dry eye disease, a widespread condition that is under-treated with currently
available medicines. ISV-101 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 anticipates initiating a Phase 1/2 clinical trial in 2011 to evaluate the safety and
efficacy of ISV-101 when administered twice daily to patients suffering from dry eye disease. The
five-arm trial design will include three ISV-101 dose concentrations and comparisons against
DuraSite and non-DuraSite (placebo) vehicles. Data from the Phase 1/2 study are expected to
provide guidance on the ideal dose for ISV-101 and the design of a Phase 3 clinical program.
“I am proud of our team’s ability to expand our clinical development pipeline by advancing this
novel new drug candidate for the treatment of dry eye disease,” said Timothy Ruane, Chief
Executive Officer of InSite Vision. “Dry eye is a serious chronic condition, and the unique and
proven attributes of our DuraSite technology, combined with the approved NSAID bromfenac, are
expected to create an effective new therapy that improves the treatment of dry eye disease. With
patent protection extending into 2029, we believe ISV-101 can be well positioned to compete in
the expanding $500 million U.S. dry eye market.”
Dry eye disease occurs when the eye does not produce sufficient tears. While causes of dry eye
may vary, it is frequently associated with inflammation of the surface of the eye, the lacrimal
gland, or the conjunctiva. A potentially chronic condition that can occur at any age, dry eye
disease is most prevalent among the elderly. It is estimated to affect five million people age 50
and older in the U.S. alone.
ISV-101 incorporates a low concentration of bromfenac with InSite Vision’s proven DuraSite
polymer technology. DuraSite extends the duration of drug residence on the surface of the eye to
facilitate better penetration, thereby potentially improving efficacy, safety and dosing of a given
therapeutic. Initial data from clinical studies evaluating the combination of DuraSite with a higher
dose of bromfenac have demonstrated a favorable safety profile. Due to its distinct mode of
action, ISV-101 is expected to act as a complimentary treatment to Restasis® (marketed by
Allergan, Inc.) for patients with dry eye disease. Restasis is currently the largest selling dry eye
treatment in the United States for patients with chronic dry eye.
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 multiple other 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. 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, ISV-303 for pain and swelling associated with ocular surgery, and
ISV-101 for the treatment of dry eye disease. 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 initiate a Phase 1/2 clinical trial for ISV-101 and the timing
thereof, expected indications for, and potential advantages of, ISV-101, the potential market size
for ISV-101, the expected benefits of ISV-101 and plans for a subsequent Phase 3 trials for ISV-
101. Such statements entail a number of risks and uncertainties, including but not limited to: the
results of clinical trials for ISV-101; 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-101 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.
1
Source: National Eye Institute “Facts About Dry Eye”
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.
Contact Information
BCC Partners
Michelle Corral
415.794.8662
InSite Vision
Louis Drapeau, Chief Financial Officer
510.747.1220
mail@insite.com
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