Top-Line Results Anticipated to be Available in the First Half of 2011
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB:INSV), a company developing novel ophthalmic therapeutics, today announced that patient enrollment was recently completed in the company’s Phase 1/2 clinical trial of ISV-303, a novel compound being developed to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the non-steroidal anti-inflammatory (NSAID) bromfenac (BROMDAY™/Xibrom™ marketed by ISTA Pharmaceuticals) with InSite Vision’s proprietary DuraSite® technology.
InSite Vision commenced the Phase 1/2 clinical trial in August and enrolled approximately 160 eligible patients undergoing cataract surgery. The study is designed to evaluate the safety and efficacy of ISV-303 when administered either once or twice daily. Patients were randomized into one of four study arms examining ISV-303 as compared to the commercial bromfenac (once or twice daily) or vehicle (e.g., DuraSite). Patient dosing and follow-up for the Phase 1/2 clinical trial is expected to be completed during January, and InSite anticipates announcing top-line results in the first half of 2011. Data from this study are expected to provide guidance on the design of a Phase 3 clinical program. InSite Vision anticipates an additional Phase 2 clinical trial for ISV-303 to investigate, among other things, the pharmacokinetics of ISV-303 in humans.
“We are very pleased by our team’s performance on the accelerated rate of enrollment of this Phase 1/2 clinical trial, which was one of the fastest rates on record for a trial of this size and design,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “We believe the combination of our DuraSite technology with the approved NSAID bromfenac may create a superior new therapy to improve the outcome of patients undergoing ocular surgery. With an improved efficacy and safety profile, and patent protection extending into 2029, we believe ISV-303 is well positioned to compete in the expanding $300 million ophthalmic NSAID U.S. market.”
Based on promising head-to-head preclinical results evaluating ISV-303 versus commercially-available bromfenac, in both single- and multi-use settings, InSite Vision believes ISV-303 has the potential to offer improved efficacy and safety advantages. These head-to-head data have been accepted for publication in a prominent peer-reviewed journal, with publication anticipated in the first quarter of 2011.
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 enhance healing.
ISV-303 is designed to extend the duration of drug residence on the surface of the eye to facilitate better penetration, while potentially improving the efficacy and safety profile, particularly for the prevention of cystoid macular edema. ISV-303 combines a low concentration of bromfenac with DuraSite, InSite Vision’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-303’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 InSite Vision
InSite Vision is committed to 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 Inspire Pharmaceuticals, 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 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 complete Phase 1/2 clinical trial for ISV-303 and the timing thereof and for announcing results thereof, expected indications for, and potential advantages of, ISV-303, the potential market size for ISV-303, the expected benefits of ISV-303 and plans for a subsequent Phase 2 and 3 trials for ISV-303. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for ISV-303; the timing of completion of the Phase 1/2 clinical trial, InSite’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.
BROMDAY™/Xibrom™ (bromfenac ophthalmic solution) 0.09%, is a trademark of ISTA Pharmaceuticals.
BESIVANCE™ is a trademark of Bausch & Lomb Incorporated.
Louis Drapeau, 510-747-1220
Chief Financial Officer
Michelle Corral, 415-794-8662
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Surgery Health Biotechnology Clinical Trials Optical Pharmaceutical