InSite Vision Regains Development Rights for AzaSite Xtra™

  InSite Vision Regains Development Rights for AzaSite Xtra™

Potential Product to Extend AzaSite^® Ophthalmology Franchise Through 2027 and
                                    Beyond

Business Wire

ALAMEDA, Calif. -- June 21, 2013

InSite Vision Incorporated (OTCBB: INSV) today announced that the company has
regained North American development rights to azithromycin ophthalmic solution
2%, trademarked as AzaSite Xtra™, from Inspire Pharmaceuticals Inc., a
subsidiary of Merck & Co., Inc., known as MSD outside the United States and
Canada. AzaSite Xtra, formulated in InSite’s DuraSite^® topical drug delivery
system, is a product candidate intended for the topical treatment of ocular
infections.

“We are excited for the opportunity to develop AzaSite Xtra,” said Timothy
Ruane, Chief Executive Officer of InSite Vision. “We believe InSite’s
capabilities as a nimble, efficient drug developer will allow us to speed the
development of AzaSite Xtra.”

Under the terms of the agreement, a joint development committee composed of
representatives from both companies will oversee development and submission of
applications for regulatory approval in the USA and Canada for AzaSite Xtra.
Merck retains an option to acquire AzaSite Xtra for a one-time payment and
royalties on any product sales.

In 2007, Insite Vision licensed exclusive rights to commercialize AzaSite^®
and AzaSite Xtra for ocular infections in the United States and Canada to
Inspire Pharmaceuticals (subsequently acquired by Merck in May 2011).

AzaSite (azithromycin ophthalmic solution) 1% is indicated for the treatment
of bacterial conjunctivitis in patients one year and older caused by the
following organisms: CDC cornyeform group G, Haemophilus influenzae,
Staphylococcus aureus, Streptococcus mitis group, and Streptococcus
pneumoniae. AzaSite is formulated using InSite Vision’s proprietary DuraSite
drug delivery technology that extends the duration of drug retention on the
surface of the eye. AzaSite Xtra is a higher dose (2.0%) of azithromycin
ophthalmic solution formulated in DuraSite and being developed for the topical
treatment of ocular infections. InSite Vision has previously completed all
formulation/stability data and all GLP toxicology work to support global
Investigational New Drug application filings. AzaSite Xtra has patent
protection into 2027, with additional applications filed or pending.

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 the possible development of AzaSiteXtra,
possible additional AzaSiteXtra indications beyond bacterial conjunctivitis,
and the possible repurchase of AzaSiteXtra by Merck at a later date. Such
statements entail a number of risks and uncertainties, including but not
limited to: the results of clinical trials for AzaSiteXtra and the timing
thereof, InSite’s ability to obtain FDA acceptance of a New Drug Application
for AzaSiteXtra 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, including AzaSiteXtra, to include additional
indications; that Merck may exercise its option to reacquire AzaSite Xtra in
the future, which could limit the economic value of AzaSite Xtra to InSite;
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 andone 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.

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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