ISV Insite Vision

InSite Vision Incorporated (AMEX:ISV) announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb�s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision�s DuraSite� patented drug delivery system. DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. By increasing the time that a therapeutic level of medication remains on the eye�s surface, DuraSite enables a less frequent dosing schedule, increased patient compliance, and increased efficacy. Bausch & Lomb is developing this broad-spectrum, anti-infective drop specifically for ophthalmic use, and receipt of unanimous recommendation by this FDA advisory committee is a key step in the approval review process for a new drug application. Bausch & Lomb licensed the besifloxacin DuraSite formulation from InSite Vision in 2003 following Phase 1 clinical studies and continued the development to this NDA filing. Based on the terms of the agreement, InSite will receive competitive single-digit royalties on sales of the approved product. �This positive recommendation by the FDA�s Dermatologic and Ophthalmic Drugs Advisory Committee further demonstrates the clinical value of the DuraSite technology in new products promising valuable approaches to treating common eye care conditions,� said Louis Drapeau, InSite�s Chief Executive Officer. �This new Bausch & Lomb agent has the potential to be the second approved product incorporating our DuraSite platform. We continue to look for new opportunities to develop pharmaceutical products utilizing this novel technology platform.� 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 development status of certain products utilizing the DuraSite technology platform. 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.