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InSite Vision (ISV) Files IND for ISV-101 with the U.S. FDA for the Treatment of Dry Eye Disease


1/11/2011 11:00:18 AM

ALAMEDA, Calif. – January 11, 2011 – InSite Vision Incorporated (OTCBB: INSV) today announced that it has filed an Investigational New Drug (IND) application for ISV-101 with the U.S. Food and Drug Administration (FDA). ISV-101 is InSite Vision's novel compound being developed to treat dry eye disease, a widespread condition that is under-treated with currently available medicines. ISV-101 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 anticipates initiating a Phase 1/2 clinical trial in 2011 to evaluate the safety and efficacy of ISV-101 when administered twice daily to patients suffering from dry eye disease. The five-arm trial design will include three ISV-101 dose concentrations and comparisons against DuraSite and non-DuraSite (placebo) vehicles. Data from the Phase 1/2 study are expected to provide guidance on the ideal dose for ISV-101 and the design of a Phase 3 clinical program.

“I am proud of our team’s ability to expand our clinical development pipeline by advancing this novel new drug candidate for the treatment of dry eye disease,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “Dry eye is a serious chronic condition, and the unique and proven attributes of our DuraSite technology, combined with the approved NSAID bromfenac, are expected to create an effective new therapy that improves the treatment of dry eye disease. With patent protection extending into 2029, we believe ISV-101 can be well positioned to compete in the expanding $500 million U.S. dry eye market.”

Dry eye disease occurs when the eye does not produce sufficient tears. While causes of dry eye may vary, it is frequently associated with inflammation of the surface of the eye, the lacrimal gland, 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 five million people age 50 and older in the U.S. alone.

ISV-101 incorporates a low concentration of bromfenac with InSite Vision’s proven DuraSite polymer technology. DuraSite extends the duration of drug residence on the surface of the eye to facilitate better penetration, thereby potentially improving efficacy, safety and dosing of a given therapeutic. Initial data from clinical studies evaluating the combination of DuraSite with a higher dose of bromfenac have demonstrated a favorable safety profile. Due to its distinct mode of action, ISV-101 is expected to act as a complimentary treatment to Restasis® (marketed by Allergan, Inc.) for patients with dry eye disease. Restasis is currently the largest selling dry eye treatment in the United States for patients with chronic dry eye.

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™ (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 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, 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.

Forward-looking Statements This news release contains certain statements of a forward looking nature relating to future events, including, InSite's plans to initiate a Phase 1/2 clinical trial for ISV-101 and the timing thereof, expected indications for, and potential advantages of, ISV-101, the potential market size for ISV-101, the expected benefits of ISV-101 and plans for a subsequent Phase 3 trials for ISV- 101. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for ISV-101; 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-101 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.

1 Source: National Eye Institute “Facts About Dry Eye” 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.

Contact Information

BCC Partners Michelle Corral 415.794.8662

InSite Vision Louis Drapeau, Chief Financial Officer 510.747.1220 mail@insite.com

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