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InSite Vision Commences Phase 1/2 Clinical Study of ISV-303 for Post-Surgical Ocular Pain and Swelling

^{Published on 2010-08-23 05:55:36 - Market Wire}
 

ALAMEDA, Calif.--([ BUSINESS WIRE ])--InSite Vision Incorporated (OTCBB:INSV), a company developing novel ophthalmic therapeutics, today announced the initiation of a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the non-steroidal anti-inflammatory (NSAID) bromfenac with InSite Visiona™s proprietary DuraSite® technology.

"Bromfenac and similar topical NSAIDs are regularly used to manage ocular inflammation and pain following cataract surgeries and other procedures; however, we believe there is a significant opportunity to improve on existing products"

The randomized, placebo-controlled Phase 1/2 clinical trial is designed to evaluate the safety, efficacy and pharmacokinetics of ISV-303. Approximately 160 patients will be enrolled in one of four study arms to receive ISV-303 administered once-daily; ISV-303 administered twice-daily; vehicle; or an approved topical anti-inflammatory agent administered twice-daily. Patients will receive drug therapy following an ocular surgery procedure for two weeks, with two-weeks of follow-up. Results will be measured by patient response assessment of pain and overall satisfaction, combined with an objective assessment by the treating physician utilizing ophthalmic tests and diagnostics. While the trial is not designed to achieve statistical significance, results from this study are expected to provide guidance on the design of a Phase 3 clinical program.

aBromfenac and similar topical NSAIDs are regularly used to manage ocular inflammation and pain following cataract surgeries and other procedures; however, we believe there is a significant opportunity to improve on existing products,a said Kamran Hosseini, M.D., Ph.D., Vice President, Clinical Affairs and Chief Medical Officer of InSite Vision. aLeveraging our proven DuraSite technology to extend the duration of drug delivery to the eye, ISV-303 has the potential to offer important advantages in relieving pain and discomfort, as well as improving dosing convenience. We expect to report initial data from this Phase 1/2 clinical study in early 2011 and these results will guide the design of Phase 3 studies, which could begin as early as the second half of 2011.a

Cataract surgery is the most frequently performed ocular surgery in the United States, with more than three million procedures in the U.S. each year. Following surgery, anti-inflammatory eye drops are typically prescribed to reduce pain and enhance healing.

ISV-303 is intended to extend the duration of drug residence on the eyea™s surface to facilitate better penetration and thus reduce dosing, while potentially improving the efficacy profile. ISV-303 combines a low concentration of bromfenac (Xibroma", marketed by ISTA Pharmaceuticals) with DuraSite, InSite Visiona™s proven bioadhesive polymer technology. In preclinical studies, ISV-303 demonstrated a superior delivery and ocular distribution profile when compared to the commercially available bromfenac eye drop. Further, ISV-303a™s improved distribution profile was consistent across all ocular tissues, including both the front and back of the eye. InSite Vision is initially developing ISV-303 for use in a post-operative setting to suppress or reduce inflammation and eye pain.

About DuraSite®

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® (azithromycin ophthalmic solution) 1% and Besivancea" (besifloxacin ophthalmic suspension) 0.6%. InSite vision is also applying DuraSite to other clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.

About InSite Vision

InSite Vision is committed to advancing new and superior ophthalmologic products for unmet eye care needs. The companya™s product portfolio utilizes InSite Visiona™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 Inspire Pharmaceuticals, and Besivancea" (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb and their partner Pfizer Inc. InSite Visiona™s clinical-stage ophthalmic product pipeline includes ISV-502 and ISV-305 for the treatment of eye infections, and ISV-303 for pain and swelling 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, InSite's plans to commence Phase 1/2 clinical trials for ISV-303 and the timing thereof, expected indications for, and advantage of, ISV-303, and the expected benefits of ISV-303. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for ISV-303; InSitea™s ability to obtain Food and Drug Administration (FDA) approval to commence additional clinical trials for ISV-303 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.

Xibroma" (bromfenac ophthalmic solution) 0.09%, is a trademark of ISTA Pharmaceuticals.

BESIVANCEa" is a trademark of Bausch & Lomb Incorporated.