Health & Fitness
Health and Fitness
Health and Fitness
Wed, June 1, 2011
Tue, May 31, 2011 
ALAMEDA, Calif.--([ BUSINESS WIRE ])--InSite Vision Incorporated (OTCBB: INSV) today announced it has established a new website for AzaSite Plus ([ www.AzaSitePlus.com ]), a late-stage product candidate currently in development for the potential treatment of blepharitis. The website provides a central location for all clinical and regulatory updates and will be a useful source of information for the public, interested patients suffering from blepharitis and potential commercial partners.
InSite recently received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the design of the companya™s Phase 3 DOUBle (Dual Ophthalmic agents Used in Blepharitis) clinical trial, which is simultaneously evaluating two of InSitea™s most promising ophthalmic therapeutics, AzaSite Plusa" and DexaSitea" in patients with blepharitis. InSite also hosted a conference call to describe in detail the design of and endpoints for companya™s novel Phase 3 DOUBle trial. The conference call presentation is available on the [ www.AzaSitePlus.com ]website under the Phase III/SPA Program for all interested parties.
AzaSite Plus (ISV-502) is in advanced development for the treatment of conditions such as blepharitis that involve bacterial infection and inflammation. AzaSite Plus is a proprietary fixed-dose combination of an antibiotic (1.0% azithromycin) and an anti-inflammatory steroid (0.1% dexamethasone). A Phase 3 candidate in InSitea™s AzaSite® family of products, AzaSite Plus is formulated with InSitea™s DuraSite® drug delivery technology.
About Blepharitis
Blepharitis, also known as lid margin disease, is a common and complex eye disease that is frequently under- or misdiagnosed. Characterized by inflammation of the eyelid, blepharitis is a chronic and recurring condition for which there is currently no FDA-approved treatment. Estimated to affect 34 million patients in the U.S. alone, blepharitis symptoms include redness, irritation and scaly skin at the edges of the eyelids, in addition to acute flare-ups that can be painful and extremely irritating.
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 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 ].
AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.
BESIVANCEa" is a trademark of Bausch & Lomb Incorporated.
