Health & Fitness
Health and Fitness
Health and Fitness
Thu, May 26, 2011
Wed, May 25, 2011 InSite Vision Receives Special Protocol Assessment from the FDA for the DOUBle Phase 3 Clinical Trial of AzaSite Plusa" and Dex
ALAMEDA, Calif.--([ BUSINESS WIRE ])--InSite Vision Incorporated (OTCBB:INSV) today announced that the Company has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial of AzaSite Plusa" (ISV-502) and DexaSitea" (ISV-305) in patients with blepharitis. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study will seek to enroll 900 patients suffering from moderate-to-severe blepharitis in a four-arm trial designed to evaluate both product candidates simultaneously. An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsora™s Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission.
aThe SPA Agreement with the FDA represents a thorough and collaborative effort between the Company and the Agency that we believe provides the best chance for AzaSite Plus and/or DexaSite to be the first drugs approved for the treatment of blepharitis. The clinical development team at InSite Vision, led by our Chief Medical Officer, Dr. Kamran Hosseini, did a spectacular job in reaching this agreement with the Agency,a said Timothy Ruane, Chief Executive Officer of InSite Vision.
InSite Vision is developing two Phase 3 product candidates formulated with the Companya™s proprietary DuraSite® drug delivery platform for the treatment of blepharitis. AzaSite Plus, combines dexamethasone 0.1% with the antibiotic AzaSite® (azithromycin 1% ophthalmic solution) in DuraSite for the treatment of acute and chronic blepharitis. DexaSite, which combines dexamethasone 0.1% with DuraSite, is intended to rapidly reduce inflammation in non-bacterial blepharitis.
Mr. Ruane continued, aBlepharitis is a complex, chronic condition in which patients experience acute flare-ups. It has been estimated that 34 million people in the United States suffer from blepharitis for which there is currently no approved pharmaceutical treatment. Based on our clinical experience with AzaSite Plus and DexaSite, including a completed Phase 3 study in blepharoconjunctivitis, we believe that the design of the DOUBle Phase 3 program provides us with a unique opportunity to advance two promising products for the treatment of this disease in a single study.a
Phase 3 Trial Design
The controlled and blinded multicenter Phase 3 clinical trial will enroll patients into one of four study arms to assess the efficacy and safety of both AzaSite Plus and DexaSite in treating blepharitis. Patients will be randomized to receive treatment with AzaSite Plus, DexaSite, AzaSite, or the DuraSite vehicle twice-daily for 14 days. AzaSite Plus efficacy will be measured against the ocular antibiotic AzaSite and the DuraSite vehicle for the resolution of the clinical signs and symptoms of blepharitis. The efficacy of AzaSite Plus will also be measured against DexaSite in terms of time to recurrence in patients who achieved complete resolution of clinical signs and symptoms of blepharitis following the treatment period. The efficacy and safety of DexaSite and AzaSite will be measured against the DuraSite vehicle for resolution of clinical signs and symptoms of blepharitis. Finally, all patients who do not experience complete resolution of clinical signs and symptoms of blepharitis following the treatment period will continue to be assessed during the follow-up period for improvements or exacerbation of their disease. The follow-up period will be six months. Patients will be quantitatively assessed using a proprietary physician scoring tool, BleSSSED, and also by standardized digital photography. The study will utilize a proprietary quality of life (BleQOLITY) questionnaire developed by InSite Vision in collaboration with leading clinicians and academic experts and the FDA to assess patient treatment experience and longitudinal comfort levels.
Blepharitis, also known as lid margin disease, is a very common eye disease in the United States and internationally. Characterized by inflammation of the eyelid, blepharitis is a chronic and recurring condition for which there is currently no FDA-approved treatment. The acute flare-ups of this disease can be painful and extremely irritating.
InSite Vision to Host Conference Call and Webcast
InSite Vision management will host a conference call/webcast presentation today to review the Phase 3 protocol, including trial design and endpoints, as well as supporting clinical data for AzaSite Plus and DexaSite. The conference call and webcast will begin at 4:45 p.m. Eastern Time/1:45 p.m. Pacific Time.
The webcast presentation can be accessed live from the Investors page of the InSite Vision website. To access the live webcast, please log on several minutes prior to the scheduled start time.
Analysts and investors can participate in the conference call by dialing 877-407-8035 for domestic callers and 201-689-8035 for international callers. A telephone replay will be available following the conclusion of the call by dialing 877-660-6853 for domestic callers and 201-678-7415 for international callers. All callers will need to enter the account number 286 and conference ID 373429. An archived replay of this investor event will be available on the InSite Vision website approximately one hour after the presentation and will be archived for four weeks.
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 and Besivancea" (besifloxacin 0.6% ophthalmic suspension). 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 1% ophthalmic solution), marketed in the U.S. by Inspire Pharmaceuticals, a wholly-owned subsidiary of Merck; and Besivancea" (besifloxacin 0.6% ophthalmic suspension), marketed by Bausch & Lomb and their partner Pfizer Inc. InSite Visiona™s clinical-stage ophthalmic product pipeline includes AzaSite Plusa" (ISV-502) and DexaSitea" (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 planned Phase 3 trials for AzaSite Plus and DexaSite, the design, timing and potential outcome of same, and the expected benefits of the AzaSite Plus and/or DexaSite products. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for AzaSite Plus and DexaSite and the timing thereof; InSitea™s ability to obtain FDA approval of AzaSite Plus and/or DexaSite 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.
BESIVANCEa" is a trademark of Bausch & Lomb Incorporated.
