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InSite Vision Announces Positive Phase 1/2 Results for ISV-303 for the Reduction of Pain and Inflammation after Cataract Surger

^{Published on 2011-03-22 05:46:03 - Market Wire}
 

ALAMEDA, Calif.--([ BUSINESS WIRE ])--InSite Vision Incorporated (OTCBB:INSV) today announced top-line results from its recently completed Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery. This randomized four-arm study compared once- and twice-daily doses of ISV-303 versus Xibroma" and DuraSite^® (vehicle), each administered twice-daily. ISV-303 combines a lower dose (0.075%) of the non-steroidal anti-inflammatory (NSAID) bromfenac (BROMDAY^a"/Xibrom (bromfenac ophthalmic solution) 0.09%, marketed by ISTA Pharmaceuticals) with InSite Visiona™s proprietary DuraSite drug delivery technology.

"It is a delightfully rare situation to experience such stunningly statistically significant results in an exploratory Phase 1/2 study"

The Phase 1/2 clinical trial enrolled 169 patients undergoing cataract surgery. The primary endpoint of the study was the absence of cells in the anterior chamber of the eye at day 15 post surgery. Once-daily ISV-303 achieved statistically significant superiority compared to vehicle (53.3% vs. 19.0%, p=0.0016) for the primary endpoint. Further, secondary endpoints such as reduction of flare, pain and discomfort as a result of inflammation, achieved statistically significant superiority at days 8, 15 and 29 as compared with vehicle. While once-daily ISV-303 achieved a numerically superior difference in the primary endpoint versus twice-daily Xibrom (53.3% vs. 42.2%), the results did not reach statistical significance given the relatively small size of the trial. ISV-303, Xibrom and vehicle were all generally well tolerated and there were no safety concerns or serious adverse events related to any of the agents. InSite Vision intends to present a final analysis of the ISV-303 Phase 1/2 clinical trial in conjunction with a future scientific meeting.

The exploratory Phase 1/2 study was not designed to achieve statistically significant difference between the arms. Nevertheless, the results of this relatively small study comfortably demonstrate the clear efficacy and safety of once-daily ISV-303 over DuraSite in terms of a regulatory pathway, and the promise of a commercially superior once-daily NSAID for post-surgical use in the marketplace. Following final analysis, the Company plans to initiate discussions with the U.S. Food and Drug Administration (FDA) on the design of the pivotal Phase 3 program for once-daily ISV-303. The Company also plans to conduct a Phase 2 pharmacokinetic study of once-daily ISV-303 against ISTA Pharmaceuticala™s currently marketed once-daily NSAID, BROMDAY.

aIt is a delightfully rare situation to experience such stunningly statistically significant results in an exploratory Phase 1/2 study,a said Timothy Ruane, Chief Executive Officer of InSite Vision. aWith the efficacy and safety profile established in this study, and potential patent protection extending to 2029, we believe once-daily ISV-303 is very well positioned to compete in the growing $300 million ophthalmic NSAID market in the United States. Importantly, the results of this study further transform InSite Vision into a late-stage company with three Phase 3 candidates that we intend to move toward approval.a

InSite Vision is advancing another product candidate that utilizes a low-concentration of bromfenac enabled by DuraSite. ISV-101, a lower dose of bromfenac in DuraSite, is being developed for the treatment of dry eye disease. On January 11, 2011, InSite Vision announced it had filed an Investigational New Drug (IND) application for ISV-101 with the FDA. The Company is now positioned to initiate a dose-ranging Phase 1/2 clinical trial in 2011 to evaluate the safety and efficacy of ISV-101 when administered to patients suffering from dry eye disease. Patent protection for this drug candidate is also expected to extend into 2029. Preclinical data on the safety of ISV-303 and ISV-101 (bromfenac formulated in DuraSite) on ocular tissues have been accepted for presentation at the 2011 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held May 1 a" 5, 2011 in Fort Lauderdale, Florida.

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

Dry eye disease occurs when the surface of the eye becomes compromised for various reasons, frequently involving tear-film changes. While causes of dry eye may vary, it is frequently associated with inflammation of the surface of the eye, the lacrimal gland, and/or the conjunctiva. A potentially chronic condition that can occur at any age, dry eye disease is most prevalent among the elderly. It is estimated to affect at least twenty-five million people in the U.S. alone.

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 Besivance^a" (besifloxacin ophthalmic suspension) 0.6%. 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 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 Besivance^a" (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb and their partner Pfizer Inc. InSite Visiona™s clinical-stage ophthalmic product pipeline includes AzaSite Plus^a" (ISV-502) and DexaSite^a" (ISV-305) for the treatment of eye infections, ISV-303 for pain and inflammation 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, the statements in the CEO quote set forth above, plans to initiate a further Phase 2 clinical study of ISV-303 and the timing thereof, plans to discuss with the FDA possible future Phase 3 studies for ISV-303 and the timing thereof, plans to initiate a Phase 1/2 clinical trial for ISV-101 and the timing thereof, expected indications for, and potential advantages of, ISV-303 and ISV-101, the potential market sizes for ISV-303 and ISV-101, the expected patent protection period for ISV-101; and the expected benefits of ISV-303 and ISV-101. Such statements entail a number of risks and uncertainties, including but not limited to: the results of future clinical trials for ISV-303 and ISV-101; the timing of completion of the ISV-101 Phase 1/2 clinical trials, InSitea™s ability to obtain FDA approval to commence additional clinical trials for ISV-303 or ISV-101 and the timing and results thereof; InSitea™s ability to ultimately obtain FDA approval for ISV-303 and ability to successfully partner and commercialize any approved drug; even if approved, ISV-303 and InSitea™s other drug candidates may not achieve significant market acceptance; 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.

DuraSite^® is a registered trademark of InSite Vision Incorporated.

BESIVANCE^a" is a trademark of Bausch & Lomb Incorporated.