ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB:INSV) today announced the selection of Quintiles as the contract research organization to manage the DOUBle Phase 3 clinical trial of AzaSite Plus (ISV-502) and DexaSite (ISV-305) for the treatment of blepharitis. Quintiles is the world's only fully-integrated pharmaceutical services organization offering clinical, commercial, consulting and capital solutions worldwide.
"We are very pleased to partner with Quintiles for our pending DOUBle Phase 3 clinical trial. Quintiles' extensive track record in facilitating the development and commercialization of best-selling drugs significantly reduces execution risks, while providing InSite with access to a wealth of potential services that we may utilize in the future," said Timothy Ruane, Chief Executive Officer of InSite Vision.
In May 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 for the treatment of blepharitis. Both product candidates are formulated with the company's proprietary DuraSite® drug delivery platform: AzaSite Plus combines dexamethasone 0.1% with the antibiotic AzaSite® (azithromycin 1% ophthalmic solution) in DuraSite and DexaSite combines dexamethasone 0.1% with DuraSite. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study will seek to enroll approximately 900 patients suffering from moderate-to-severe blepharitis in a four-arm trial designed to evaluate both product candidates simultaneously.
Blepharitis, also known as lid margin disease, is a very common eye disease in the United States and internationally. Characterized by inflammation of the eyelid, blepharitis is a chronic and recurring condition for which there is currently no FDA-approved treatment.
InSite's DuraSite sustained delivery technology is a patented 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 also applying DuraSite to multiple other clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.
About InSite Vision
InSite Vision is advancing new and superior 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 and their partner Pfizer Inc. InSite Vision's clinical-stage ophthalmic product pipeline includes AzaSite PlusTM (ISV-502) and DexaSiteTM (ISV-305) for the treatment of eye infections, BromSiteTM (ISV-303) 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.
This news release contains certain statements of a forward looking nature relating to future events, including InSite's planned Phase 3 trials for AzaSite Plus and DexaSite, the design, timing and potential outcome of same, and the expected benefits of the AzaSite Plus and/or DexaSite products. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for AzaSite Plus and DexaSite 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 for the commercialization of its products; 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.
Louis Drapeau, 510-747-1220
Chief Financial Officer
Media and Investor inquiries:
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509