InSite Vision Receives Notice of Allowance from USPTO for Patent on DuraSite® 2 Ophthalmic Drug Delivery System

  InSite Vision Receives Notice of Allowance from USPTO for Patent on
  DuraSite® 2 Ophthalmic Drug Delivery System

  New Therapeutics Formulated in Novel Platform Technology Expected to Have
        Patent Protection to 2029 for Internal Pipeline and Partnering

Business Wire

ALAMEDA, Calif. -- July 2, 2013

InSite Vision Incorporated (OTCBB: INSV) today announced that it has received
a Notice of Allowance from the United States Patent and Trademark Office
(USPTO) on its DuraSite^® 2 ^ next-generation enhanced drug delivery system.
DuraSite 2 provides a broad platform for developing topically delivered ocular
drugs with enhanced tissue penetration in order to improve efficacy and dosing
convenience. The patent is expected to provide protection to 2029 for both the
delivery system and the drugs that are formulated with DuraSite 2.

“DuraSite 2 has demonstrated increased drug retention and tissue penetration
up to four-fold greater than a commercial ophthalmic pain reliever in
preclinical studies. Based on its potential to significantly increase efficacy
and reduce dosing requirements, we believe DuraSite 2 could serve as a
standard drug delivery technology across ophthalmic therapeutics,” said
Timothy Ruane, Chief Executive Officer of InSite Vision. “We plan to utilize
the DuraSite 2 platform in the development of all future pipeline products.
Additionally, once the patent issues, InSite plans to initiate a broad
licensing program that provides access to industry partners through both
exclusive and non-exclusive licensing and/or commercialization agreements.”

In a large-scale comparative study, a drug formulated with DuraSite 2
demonstrated significantly enhanced retention on the eye and tissue
penetration as compared to the same product alone or formulated with InSite’s
DuraSite^® technology. Results of that study showed that the DuraSite 2
formulation achieved more than 2x and 4x concentrations in the aqueous humor
of the eye compared to the DuraSite formulation or marketed drug,
respectively. The robust results of this study suggest that DuraSite 2’s
increased tissue penetration may enable it to be used in the treatment of
back-of-the-eye diseases with a topical eye drop when formulated with drugs
that must currently be administered by injection. InSite presented detailed
data from this study at the Association for Research in Vision and
Ophthalmology (ARVO) 2013 Annual Meeting. The ARVO poster presentation is
available in the publications section of InSite Vision’s website at
www.insitevision.com/publications.

About DuraSite^® and DuraSite^® 2

While eye drops are a proven delivery mechanism for numerous ocular drugs, the
efficacy of these agents is impeded by tears and blinking, which rinse the
drug from the surface of the eye and limit retention and absorption. InSite’s
DuraSite and DuraSite 2 platforms are sustained delivery technologies using a
synthetic polymer-based formulation designed to extend the residence time of a
drug relative to conventional topical therapies. DuraSite and DuraSite 2
enable 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^® and Besivance^®. InSite Vision is
advancing a portfolio of novel preclinical- to clinical-stage ophthalmic
products based on the DuraSite platform and anticipates advancing future
ophthalmic product candidates using the DuraSite 2 platform.

About InSite Vision

InSite Vision is advancing new ophthalmologic products for unmet eye care
needs based on its innovative DuraSite^® platform technologies. The DuraSite
and DuraSite 2 drug delivery systems extend the duration of drug retention on
the surface of the eye, thereby reducing the frequency of treatment and
improving the efficacy of topical 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 Merck, and Besivance^® (besifloxacin
ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also
advancing three novel ophthalmic therapeutics through Phase 3 clinical
studies: AzaSite Plus^™ and DexaSite^™ for the treatment of eye inflammation,
and BromSite^™ for pain and inflammation 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 planned use of DuraSite 2 to
formulate future drug candidates; the expected duration of patent protection
until 2029, InSite’s plans to license DuraSite 2 to third parties, and the
expected benefits of the DuraSite 2 drug delivery system. Such statements
entail a number of risks and uncertainties, including but not limited to: the
ability to formulate DuraSite 2 with existing drugs; that the results of
future clinical trials for product candidates formulated in DuraSite 2 may not
meet InSite’s clinical endpoints or match the results achieved in prior
clinical trials; InSite’s ability to obtain FDA approval of DuraSite 2 enabled
drugs; InSite’s ability to successfully license DuraSite 2 to third parties;
the risk that DuraSite 2 may not be commercially accepted; the risk that the
DuraSite 2 patent could be invalidated or challenged by the USPTO or others or
that its duration could be truncated; 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, 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^®, DuraSite^® 2 and DuraSite^® are registered trademarks of InSite
Vision Incorporated.
AzaSite Plus^™, BromSite^™ and DexaSite^™ are trademarks of InSite Vision
Incorporated.
BESIVANCE^® is a registered trademark of Bausch + Lomb Incorporated.

Contact:

InSite Vision
Louis Drapeau, 510-747-1220
Chief Financial Officer
mail@insite.com
or
Media and Investor Inquiries:
BCC Partners
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509
 
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