InSite Vision Completes DOUBle Phase 3 Clinical Study of AzaSite Plus™ and DexaSite™ for the Treatme

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InSite Vision Completes DOUBle Phase 3 Clinical Study of AzaSite Plusand DexaSitefor the Treatment of Blepharitis

Last Patient Concludes Dosing and Evaluation

ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB: INSV) today announced that the last patient has completed dosing and evaluation in the DOUBle Phase 3 clinical trial of AzaSite Plus™ and DexaSite™ for the treatment of blepharitis. There are more than 34 million blepharitis sufferers in the United States who currently have no FDA-approved drug therapies available to them.


The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study enrolled more than 900 patients with moderate-to-severe blepharitis in a four-arm trial designed to evaluate the efficacy and safety of both product candidates simultaneously. InSite Vision expects that top-line data from the DOUBle Phase 3 clinical trial will be available in the second quarter of 2013.

About the DOUBle Phase 3 Clinical Trial

In 2011, InSite Vision obtained a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the DOUBle Phase 3 clinical trial of AzaSite Plus and DexaSite in treating blepharitis. AzaSite Plus and DexaSite are formulated with InSite Vision's DuraSite® drug delivery platform: AzaSite Plus combines the corticosteroid dexamethasone 0.1% with the antibiotic azithromycin 1% in DuraSite and DexaSite combines dexamethasone 0.1% with DuraSite.

InSite designed two proprietary tools to standardize the assessment of blepharitis symptom severity and thereby measure the improvement or exacerbation of the condition. The BleSSSED (Blepharitis Signs & Symptoms Scoring for Evaluating Disease) investigator instrument provides a scoring system for measuring and categorizing the severity of eye redness, swelling, debris and irritation. Each patient's blepharitis was evaluated throughout the study using the BleSSSED scoring system along with standardized digital photography to determine trial eligibility, to establish a baseline measurement of the individual's condition, and to monitor the resolution of/or improvement in the clinical signs and symptoms of disease following treatment. Similarly, the BleQOLITY (Blepharitis Quality Of Life In TherapY) patient questionnaire establishes - for the first time - a means of determining and measuring the treatment effect on the symptoms of blepharitis that have the greatest impact on patients' quality of life. In the Phase 3 trial, patients completed the BleQOLITY questionnaire at predetermined points throughout the study to establish a baseline and measure the improvement or exacerbation of their disease.

Patients with moderate-to-severe blepharitis (as measured using InSite Vision's proprietary BleSSSED assessment tool and standardized digital photography) were randomized into one of four study arms to receive treatment with AzaSite Plus, DexaSite, AzaSite® (azithromycin 1% ophthalmic solution), or the DuraSite vehicle twice-daily for a period of 14 days.

  • AzaSite Plus will be evaluated against AzaSite for the primary endpoint of resolution of the clinical signs and symptoms of blepharitis and against DexaSite to compare the length of time to recurrence or exacerbation of symptoms for up to six months following the treatment period.
  • The efficacy and safety of DexaSite will be measured against the DuraSite vehicle for the primary endpoint of resolution of clinical signs and symptoms of blepharitis at the end of the dosing period.
  • AzaSite Plus and DexaSite will also be evaluated for the secondary endpoint of clinical improvement of signs and symptoms as demonstrated using InSite Vision's quantitative BleSSSED and BleQOLITY tools.

Patients who did not experience complete resolution of clinical signs and symptoms of blepharitis following the treatment period continued to be assessed using the BleSSSED scoring tool, digital photography and BleQOLITY for up to a six months follow-up period to evaluate improvements in or exacerbation of their disease.

About Blepharitis

Blepharitis, also known as lid margin disease, is a common, chronic eye disease characterized by inflammation of the eyelid with periodic acute flare-ups. Symptoms of blepharitis may include redness, swelling, flaking skin, cysts, "gritty" or burning sensations, itching and vision impairment. The acute flare-ups of this disease can be painful and extremely irritating. It is estimated that greater than 34 million people in the U.S. suffer from blepharitis. There is currently no FDA- approved drug treatment for blepharitis.

About DuraSite®and DuraSite 2®

While eye drops are a proven delivery mechanism for numerous ocular drugs, 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 to deliver 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 currently advancing a portfolio of novel preclinical- to clinical-stage ophthalmic product candidates 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 ophthalmic 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 infections, 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 expected timing of reporting the results of the DOUBle Phase 3 trial,the potential benefits of AzaSite Plus and DexaSite, and InSite's plans with respect to DuraSite 2.Such statements entail a number of risks and uncertainties, including but not limited to: the results of the DOUBle trial may not meet the primary end points of the studies and top-line data may not be released on the currently expected schedule;InSite's ability to obtain FDA approval of AzaSite Plus or DexaSite and the timing thereof; InSite's reliance on third parties for the conduct and analysis of its clinical trials, including the DOUBle trial; InSite's success in commercializing its products; the ability of InSite to enter into corporate collaborations for its product candidates; 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, readers should not unduly rely on such forward looking statements andshould not assume that the information provided in this release is still valid at any later date.

AzaSite®, DuraSite® and DuraSite 2® are registered trademarks of InSite Vision Incorporated.

AzaSite Plus, BromSite and DexaSite are trademarks of InSite Vision Incorporated.

BESIVANCE® and Bromday™ are registered trademarks of Bausch + Lomb Incorporated.



InSite Vision
Louis Drapeau, Chief Financial Officer, 510-747-1220
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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The article InSite Vision Completes DOUBle Phase 3 Clinical Study of AzaSite Plus™ and DexaSite™ for the Treatment of Blepharitis originally appeared on Fool.com.

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