ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV) today announced that abstracts detailing the clinical response of blepharoconjunctivitis patients treated with dexamethasone formulated in DuraSite® and the safety of 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 1–5, 2011 in Fort Lauderdale, Florida. DuraSite, InSite’s proprietary polymer-based technology, extends the duration of drug residence on the surface of the eye to facilitate better penetration, thereby improving efficacy, safety and dosing frequency.
InSite Vision is developing two Phase 3 product candidates that utilize low concentrations of dexamethasone for the treatment of blepharitis. DexaSite™ (ISV-305), which combines dexamethasone 0.1% with DuraSite, is intended to rapidly reduce the signs and symptoms of non-bacterial blepharitis. At the upcoming ARVO Annual Meeting, InSite researchers will present data from a prior Phase 3 clinical study in patients with blepharoconjunctivitis supporting DexaSite’s efficacy and safety. DexaSite is designed to provide superior dosing, twice-a-day, compared to the commercially available dexamethosone eye drop drugs available, which require four to eight drops per day. In addition to blepharitis, DexaSite may have applications in other indications where dosing convenience impacts compliance. Patent protection for DexaSite is expected through 2029. InSite Vision’s second Phase 3-stage candidate, AzaSite Plus™ (ISV-502), combines dexamethasone 0.1% with the antibiotic azithromycin 1% in DuraSite for the treatment of bacterial blepharitis. InSite Vision has applied for a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the Phase 3 clinical trial to evaluate both AzaSite Plus and DexaSite simultaneously for the treatment of blepharitis.
InSite Vision is advancing two product candidates that utilize low-concentrations of bromfenac enabled by DuraSite. ISV-303 (0.075% bromfenac formulated in DuraSite) is intended to reduce pain and inflammation associated with cataract surgery. Enrollment in a Phase 1/2 clinical trial of ISV-303 was completed in January and topline results of this study are expected in the first half of 2011. ISV-101, a lower dose of bromfenac in DuraSite is being developed for the treatment of dry eye disease. The Company anticipates initiating 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 both of these drug candidates extends to 2029.
“The study findings that will be presented at the upcoming ARVO meeting provide additional support for the potential efficacy and safety for the Company’s principal drug development product candidates,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “With our long-lived patent protection, we believe that these product candidates hold the potential to address clear unmet medical needs of patients in the expanding eye care markets.”
Blepharitis, also known as lid margin disease, is a very common eye disease in the United States affecting up to thirty-four million people. Characterized by inflammation of the eyelid, blepharitis is a chronic and recurring condition for which there is currently no FDA-approved treatment.
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™ (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 AzaSite Plus™ (ISV-502) and DexaSite™ (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 application for a SPA from the FDA for AzaSite Plus and DexaSite, plans to report top-line data from a Phase 1/2 clinical trial 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 size for AzaSite Plus, DexaSite, ISV-303 and ISV-101, and the expected benefits of DexaSite, ISV-303 and ISV-101. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for AzaSite Plus, DexaSite, ISV-303 and ISV-101; the timing of completion of the ISV-101 Phase 1/2 clinical trials, InSite’s ability to obtain FDA approval to commence additional clinical trials for AzaSite Plus, DexaSite, ISV-303 or 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.
AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.
BESIVANCE™ is a trademark of Bausch & Lomb Incorporated.