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InSite Vision (ISV) Announces Top-Line Results From the DOUBle Phase 3 Clinical Study for the Treatment of Moderate-to-Severe Blepharitis



7/24/2013 6:53:03 AM

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InSite Vision Announces Top-line Results from the DOUBle Phase 3 Clinical Study for the Treatment of Moderate-to-Severe Blepharitis

ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (INSV) today announced top-line clinical results from the DOUBle Phase 3 clinical trial of AzaSite Plus™ and DexaSite™ for the treatment of moderate-to-severe blepharitis. AzaSite Plus and DexaSite did not meet the primary endpoint of complete resolution of all clinical signs and symptoms of blepharitis. AzaSite Plus and DexaSite did demonstrate statistically significant improvements in the clinical signs and symptoms at Day 15. The results of this landmark multi-product Phase 3 study evaluating the treatment of blepharitis further reinforce the emerging clinical viewpoint that blepharitis is a chronic and persistent disease that may require a different approach based on clinically achievable and meaningful improvement rather than a “cure” that is sought for an acute disease. This finding is consistent with the views of an increasing number of clinicians with respect to blepharitis. InSite Vision has scheduled a meeting with the U.S. Food and Drug Administration (FDA) on August 19, 2013 to review the overall results of the DOUBle Phase 3 study.

The DOUBle Phase 3 study is the largest, most quantitative and most comprehensive clinical study of blepharitis ever conducted for a disease impacting an estimated 34 million Americans. “Currently, there is no pharmaceutical agent approved to help these patients,” said Kamran Hosseini, M.D., Ph.D., and Chief Medical Officer of InSite Vision. “This Phase 3 trial was designed to improve our understanding of this complex ophthalmic condition by defining quantitative and qualitative measures of meaningful clinical improvement by which our clinical candidates could be evaluated. Our preliminary findings indicate that AzaSite Plus and DexaSite may have clinical benefit even though they did not meet the primary endpoint of the study. We plan to discuss the full clinical and Quality of Life findings of this groundbreaking study with the FDA on August 19 with the objective of determining a reasonable pathway to partner with the FDA in the investigation of AzaSite Plus and DexaSite as the first agents to be approved for the treatment of moderate-to-severe blepharitis.”

Top-line Clinical Results

The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study enrolled 907 patients with moderate-to-severe blepharitis in a randomized, double-blind, four-arm clinical trial designed to evaluate the efficacy and safety of both product candidates simultaneously. Across all arms, fewer than seven percent (

As such, none of the arms of the study reached statistical significance. However, at Day 15, there were clear statistically significant clinical improvements in the severity of disease in the AzaSite Plus and DexaSite arms of the study following 14 days of therapy. InSite believes that the results of this Phase 3 study further reinforce the emerging clinical viewpoint that blepharitis is a chronic and incurable disease which may require a different clinical approach versus a therapeutic approach for an acute disease.

Conference Call Today

InSite will host a conference call today, Tuesday, July 23, 2013, at 1:30 p.m. Pacific Time/4:30 p.m. Eastern Time. Analysts and investors can participate in the conference call by dialing 877-546-5021 for domestic callers and 857-244-7553 for international callers using the passcode 46766517. A telephone replay will be available following the conclusion of the call by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers using the passcode 63485748. The live conference call will be available on the Investor Relations page of the company's website at http://www.insitevision.com. Prior to the call, a presentation outlining these results will be posted on the company website.

Additional Findings

In the DOUBle study pre-enrollment period, a total of 1,112 subjects were clinically evaluated by an ophthalmologist and determined to suffer from moderate-to-severe blepharitis, as measured by a quantitative disease severity score (see BleSSSED below). Then, during a seven-day pre-randomization period, all patients were instructed to use twice-daily medicated eyelid wipes as basic hygiene, which is considered the de facto standard of care. Following seven days of eyelid margin hygiene, patients were again clinically evaluated by an ophthalmologist and scored for the severity of their disease to determine eligibility for the DOUBle study. Of note, only seven percent (7%) of those patients were then downgraded to mild disease and, therefore, eliminated from the study. This is the first randomized, double-blind Phase 3 clinical study that provides clear clinical proof that lid margin hygiene alone cannot be considered the standard of care in the treatment of moderate-to-severe blepharitis.

The company is still analyzing the quality-of-life patient questionnaire data (see BleQOLITY below) with experts at the University of California at Los Angeles (UCLA), and plans to release that data when it is available.

About the DOUBle Phase 3 Clinical Trial

In 2011, InSite Vision obtained a Special Protocol Assessment (SPA) from the 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 was evaluated against AzaSite for the primary endpoint of resolution of all 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 was evaluated against the DuraSite vehicle for the primary endpoint of resolution of all clinical signs and symptoms of blepharitis at the end of the dosing period.

- AzaSite Plus and DexaSite were also evaluated for the secondary endpoint of clinical improvement of signs and symptoms of blepharitis 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 month follow-up period to evaluate improvement 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, 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 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 potential benefits of AzaSite Plus and DexaSite, the future clinical development of AzaSite Plus and DexaSite, the possibility that blepharitis could be characterized as a chronic disease thereby potentially facilitating further advancement of AzaSite Plus and/or DexaSite, InSite Vision’s plans to meet with the FDA on August 19, 2013 and InSite’s plans to advance future ophthalmic candidates using the DuraSite 2 platform. Such statements entail a number of risks and uncertainties, including but not limited to: risks and uncertainties relating to the failure to achieve favorable clinical outcomes; risk and uncertainties relating to the conduct and timing of future clinical trials of AzaSite Plus and DexaSite; 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; 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; that the FDA or InSite Vision may cancel or delay the planned August 19, 2013 meeting 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 and 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. 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

BCC Partners

Media and Investor inquiries

Michelle Corral, 415-794-8662

Karen L. Bergman, 650-575-1509

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