InSite Vision Fully Enrolls Phase 3 DOUBle Clinical Study of AzaSite Plus and DexaSite for Blepharitis

ALAMEDA, Calif.--()--InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has been completed in the DOUBle Phase 3 clinical trial of AzaSite Plus (ISV-502) and DexaSite (ISV-305) for the treatment of blepharitis. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study enrolled more than 900 patients with moderate-to-severe blepharitis in less than ten months in a four-arm trial designed to evaluate the efficacy and safety of both product candidates simultaneously.

More than 1,100 patients at 44 sites entered the study screening process after being diagnosed with blepharitis. After using twice-daily lid scrubs for seven days, 81% of those patients were determined to have moderate-to-severe blepharitis and were randomized into the DOUBle clinical trial. The remaining patients, or 19%, were largely determined to have mild blepharitis, which was adequately controlled by lid scrubs alone, and were not enrolled into the trial. Currently, about 450 patients remain on-study. InSite Vision expects that the DOUBLe clinical trial will be complete and top-line data available in early 2013.

“The DOUBle Phase 3 trial is the largest and most extensive quantitative clinical study ever conducted for blepharitis. In addition to testing two promising therapeutics simultaneously, the DOUBle study is designed to significantly improve the understanding of the disease and make an important contribution to improving patient care,” said Kamran Hosseini, M.D., PhD, Vice President and Chief Medical Officer of InSite Vision. “We are committed to make AzaSite Plus and DexaSite available for the more than 34 million blepharitis sufferers in the United States who currently have no approved drug therapies available to them. While all data are blinded, during the study to date there have been no serious adverse events related to the study drugs and the drugs have been well tolerated.”

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 is 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. The BleQOLITY questionnaire was developed by InSite Vision in collaboration with leading clinicians, academic experts and the FDA to assess patient treatment experience and longitudinal comfort levels. In the Phase 3 trial, patients are asked to complete 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 will continue to be assessed using the BleSSSED scoring tool, digital photography and BleQOLITY for up to a six months follow-up period for improvements in or exacerbation of their disease.

Quintiles is the contract research organization managing the DOUBle study on behalf of InSite Vision. Additional information regarding the DOUBle clinical trial and InSite’s BleSSSED and BleQOLITY tools can be found at www.AzaSitePlus.com.

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

InSite's DuraSite sustained delivery technology is a 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® (besifloxacin 0.6% ophthalmic suspension). InSite Vision is advancing a portfolio of novel preclinical- to clinical-stage ophthalmic products based on the DuraSite platform.

About InSite Vision

InSite Vision is advancing new ophthalmologic products for unmet eye care needs. The company’s product portfolio utilizes InSite Vision’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 Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision’s clinical-stage ophthalmic product pipeline includes AzaSite Plus and DexaSite for the treatment of eye infections, BromSite 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 InSite's Phase 3 trials for AzaSite Plus and DexaSite, the protocol, design, structure, timing and potential outcome of same, and the expected benefits of the AzaSite Plus and DexaSite. Such statements entail a number of risks and uncertainties, including but not limited to: the timing of completion of the Phase 3 trials, the results of the Phase 3 trials and the timing thereof, InSite’s ability to obtain FDA approval of AzaSite Plus and/or DexaSite and the timing thereof; InSite's reliance on third parties to conduct its clinical trials, including with respect to the DOUBle Phase 3 study, Quintiles, and the effectiveness of same; InSite’s reliance on third parties for the commercialization of its products and the effectiveness of such third parties; 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® are registered trademarks of InSite Vision Incorporated.

BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.

Contacts

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

Release Summary

InSite Vision has completed enrollment of its Phase 3 DOUBle clinical trial evaluating AzaSite Plus and DexaSite in a single study for the treatment of blepharitis.

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Contacts

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