ISV Insite Vision

InSite Vision Incorporated (AMEX:ISV) today announced preliminary results from the company�s Phase 3a clinical trial of ISV-502 (AzaSite Plus�) a topical combination antibiotic/corticosteroid product for the treatment of blepharoconjunctivitis. Blepharoconjunctivitis, also known as lid margin disease, is a chronic inflammatory disease of the inside and outside of the eyelid with no approved treatment. ISV-502 improved clinical outcomes as compared to treatment with a corticosteroid alone or antibiotic alone in the reduction of inflammatory signs and symptoms and bacterial eradication, respectively. In addition, ISV-502 was very well tolerated. However, an initial evaluation of the data indicates that the trial did not achieve its primary endpoint as defined by the protocol. �A safe, convenient and effective formulation of an antibiotic and corticosteroid such as ISV-502 with the potential to address the inflammation and underlying infection would have a significant impact on the treatment of this condition. These initial data appear encouraging and I look forward to continued evaluation of this promising product,� said Mark Abelson, M.D., a clinical associate professor at Harvard Medical School. �Lid margin disease is a painful and difficult to treat condition and available treatments have limited success in alleviating symptoms or addressing the underlying cause. Patients would benefit from a treatment designed to provide both relief of the acute symptoms and to treat the underlying condition.� InSite Vision will utilize data from this Phase 3 trial in the finalization of a planned confirmatory Phase 3 clinical study. The company anticipates discussing the results of this trial with the U.S. Food and Drug Administration (FDA) in the first quarter of 2009. Following these discussions, the company will announce anticipated timing for initiating a second Phase 3 clinical trial. �Patients receiving ISV-502 achieved marked improvement in their condition. We believe that ISV-502�s performance in both addressing inflammation and eradicating bacterial infection associated with lid margin disease make continued development of this product worthwhile,� said Louis Drapeau, InSite�s Chief Executive Officer. �The study demonstrated that ISV-502 achieved a statistically significant difference when compared to treatment with an antibiotic alone for the reduction of inflammatory signs and symptoms. A statistically significant difference was also shown when ISV-502 is compared to treatment with a corticosteroid alone for bacterial eradication. We are conducting a thorough analysis of the promising trends observed in this trial as we finalize the protocol for the second Phase 3 confirmatory study to be discussed with the FDA.� The Phase 3 multi-center study was designed to evaluate the anti-inflammatory and anti-microbial effects of ISV-502 (a combination of 1% azithromycin and 0.1% dexamethasone) as compared to either AzaSite� (azithromycin ophthalmic solution 1%), InSite�s topical antibiotic eye drop currently marketed for the treatment of bacterial conjunctivitis, or dexamethasone, a commonly used corticosteroid intended to address inflammation. The primary endpoint for the trial was the clinical resolution of all inflammatory symptoms present at the time of enrollment, which could include lid margin redness or swelling, conjuctival redness or ocular discharge and lid irritation in at least one eye. The secondary endpoint was bacterial eradication. Resolution or improvement of individual symptoms and safety were also assessed. Patients were randomized into one of three dose groups and received one drop in the eye and one drop on the eyelid administered twice daily for fourteen days. A total of 417 patients with a clinical diagnosis of blepharoconjuctivitis were enrolled in the Phase 3 trial. Of the 417 patients in the study, 27.1 percent of subjects treated with ISV-502 met the clinical criteria necessary to demonstrate a resolution of the inflammatory signs and symptoms of blepharoconjunctivitis. By comparison, 15.6 percent of subjects in the AzaSite study arm and 23.5 percent of subjects receiving dexamethasone alone achieved a complete resolution of their eye clinical signs and symptoms. In addition, ISV-502 successfully achieved bacterial eradication of the eye as part of the secondary endpoint at a statistically significant difference compared with dexamethasone alone. In the ISV-502 study arm, 100 patients had positive bacterial culture confirmed in at least one eye at the time of enrollment. Of these, 60.0 percent achieved complete eradication of their bacterial load measured at their last clinical visit. By comparison, 66.3 percent in the AzaSite study arm and 40.2 percent in the dexamethasone arm achieved eradication of bacterial load. ISV-502 was very well tolerated consistent with safety data observed in past clinical and preclinical studies of the compound. The adverse events reported were mild to moderate with no serious adverse events related to the study drug. About ISV-502 (AzaSite Plus) and DuraSite� ISV-502 combines 1% azithromycin and 0.1% dexamethasone in InSite's patented DuraSite� sustained delivery vehicle to provide simultaneous antimicrobial and anti-inflammatory treatment for the treatment of eyelid infection and inflammation in adults. InSite�s DuraSite sustained delivery vehicle is a synthetic polymer-based formulation designed to achieve high tissue levels of drug relative to conventional topical therapies that are rapidly rinsed away by tears. About Blepharoconjunctivitis Blepharoconjunctivitis, also known as lid margin disease, is a frequent and recurring disease that results in the inflammation of the conjuctiva and eyelids and is caused by infections or allergic reactions. Blepharoconjunctivitis can be a chronic condition that is difficult to treat. Current available approaches are limited in their efficacy and may include eye hygiene practices, topical and/or systemic antibiotics and topical corticosteroids. About InSite Vision InSite Vision develops novel ocular pharmaceutical products using its DuraSite� bioadhesive polymer core technology to enable topical delivery and sustained release of existing drug molecules for reduced frequency of treatment and improved efficacy. By formulating the well-established antibiotic azithromycin in DuraSite, InSite developed the lowest-dosing ocular antibiotic available to the United States ophthalmic market, AzaSite� (azithromycin ophthalmic solution) 1%, launched by Inspire Pharmaceuticals in the United States for the treatment of bacterial conjunctivitis (pink eye). In addition, InSite has signed licensing and distribution agreements in South Korea; four countries in South America; Turkey; and China; and is seeking other international partners for commercialization and distribution of AzaSite. InSite is pursuing the expansion of its portfolio of anti-infective ophthalmic products to include ISV-502, which is currently in Phase 3 pivotal trials for the treatment of eye and eyelid infection and inflammation, currently an unmet need. In addition, the company is investigating other product and collaboration opportunities with both the DuraSite-azithromycin platform and/or with DuraSite and other molecules. Forward Looking Statements This news release contains certain statements of a forward looking nature relating to future events, including the proposed indications and clinical status of ISV-502 (AzaSite Plus), the benefits of ISV-502, the potential benefits of ISV-502, InSite�s plans with respect to future clinical trials for ISV-502 and discussions with the FDA regarding the same, InSite's plans to advance its AzaSite family of products, and InSite's corporate goals. Such statements entail a number of risks and uncertainties, including but not limited to: InSite's ability to commence additional clinical trials with respect to ISV-502 and InSite�s various other product candidates and the results of such trials; the clinical results of InSite's product candidates, including ISV-502; InSite's reliance on third parties for the commercialization of ISV-502 and its other products; the ability of InSite to enter into corporate collaborations for ISV-502 and with respect to its other product candidates; InSite's ability to successfully market ISV-502; InSite's ability to expand its technology 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 and ISV-502; 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, including those with respect to ISV-502. 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.