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InSite Vision Updates Special Protocol Assessment Submission to FDA for Phase 3 Trial of AzaSite Plusa" and DexaSitea"

^{Published on 2011-04-14 05:40:41 - Market Wire}
 

ALAMEDA, Calif.--([ BUSINESS WIRE ])--InSite Vision Incorporated (OTCBB:INSV) today announced that the Company recently received eight minor recommendations regarding its proposed agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of InSitea™s Phase 3 clinical trial of AzaSite Plus^a" (ISV-502) and DexaSite^a" (ISV-305) in patients with blepharitis, a chronic ophthalmic inflammatory condition that affects up to 34 million people in the United States. The Company filed its responses today accepting all recommendations from the FDA. An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsora™s Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission.

aWe appreciate the ongoing close collaboration InSite Vision has established with the FDA as we pursue an SPA agreement for the Phase 3 development of our two lead product candidates. The Agencya™s input on the design of our Phase 3 clinical trial for AzaSite Plus and DexaSite has been valuable, and we believe that by working together, we will significantly enhance the odds of InSite Vision having the first drug approved for blepharitis, a common and chronic inflammatory disease of the eye,a said Timothy Ruane, Chief Executive Officer of InSite Vision.

In preparation for final approval, InSite Vision plans to host a conference call and webcast slide presentation for investors upon receipt of the SPA agreement from the FDA to describe in detail the Phase 3 trial design, clinical endpoints, and other novel and significant aspects of the study.

InSite Vision is developing two Phase 3 product candidates that utilize low concentrations of the anti-inflammatory corticosteroid dexamethasone for the treatment of blepharitis. DexaSite, which combines dexamethasone 0.1% with DuraSite^®, is intended to rapidly reduce the signs and symptoms of non-bacterial blepharitis. Patent protection for DexaSite is expected through 2029. InSite Visiona™s second Phase 3-stage candidate, AzaSite Plus, combines dexamethasone 0.1% with the antibiotic AzaSite^® (azithromycin ophthalmic solution 1% in DuraSite) for the treatment of bacterial blepharitis. Patent protection for AzaSite Plus extends at least to 2019.

Blepharitis, also known as lid margin disease, is characterized by a chronic and recurring inflammation of the eyelid, for which there is currently no FDA-approved treatment. Acute flare-ups of this disease can be painful and extremely irritating. Blepharitis is one of the most common and frequently diagnosed eye diseases in the United States, affecting as many as 34 million people.

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 and Besivance^a" (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 companya™s product portfolio utilizes InSite Visiona™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^a" (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb and their partner Pfizer Inc. InSite Visiona™s clinical-stage ophthalmic product pipeline includes AzaSite Plus^a" (ISV-502) and DexaSite^a" (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 the information set forth in the Chief Executive Officer quote set forth above, the status of InSite's application for a SPA agreement from the FDA for AzaSite Plus and DexaSite and the implication that by addressing all of the FDAa™s comments InSite will obtain a SPA agreement with the FDA, the odds of InSite Vision having the first drug approved for blepharitis. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for AzaSite Plus and DexaSite, and InSitea™s other product candidates, InSitea™s ability to address the FDAa™s comments on the SPA and ability to obtain an SPA agreement with the FDA; InSitea™s ability to obtain FDA approval to commence additional clinical trials for AzaSite Plus and DexaSite and the timing and results 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^® is a registered trademarks of InSite Vision Incorporated.

BESIVANCE^a" is a trademark of Bausch & Lomb Incorporated.