среда, 12 сентября 2012 г.

InSite Vision Announces FDA Approval of New Ophthalmic Product Enabled by InSite's DuraSite[R] Technology. - China Business Newsweekly

InSite Vision Incorporated (OTCBB:INSV) announced that Bausch & Lomb has received approval of Besivance™ (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis ('pink eye') in patients one year and older from the U.S. Food and Drug Administration (FDA). Besivance™ is formulated with InSite Vision's DuraSite® technology, a synthetic polymer delivery vehicle that enhances the retention time of the drug on the surface of the eye.

Bausch & Lomb licensed the besifloxacin DuraSite formulation from InSite Vision in 2003 following Phase 1 clinical studies and continued development of this broad-spectrum, anti-infective drop specifically for ophthalmic use. Based on the terms of the agreement, InSite will receive competitive single-digit royalties on global net sales of the product. Besivance is being launched in the U.S. in the second quarter of 2009. The product will be promoted by the sales forces of both Bausch & Lomb and Pfizer, Inc. under a co-promotion agreement involving both companies' prescription ophthalmic pharmaceuticals.

'We expect this product to offer patients a valuable therapeutic option for one of the most common ocular conditions worldwide,' said Louis Drapeau, InSite's Chief Executive Officer. 'The launch of Besivance represents the second commercially available product incorporating InSite's DuraSite platform, in addition to AzaSite. This is an exciting milestone which further demonstrates the clinical value of the technology. We continue to look for new opportunities to utilize DuraSite to develop valuable products that treat unmet eye care needs.'

DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. By increasing the time that a therapeutic level of medication remains on the eye's surface, DuraSite enables a less frequent dosing schedule, increases patient compliance, and increases the therapeutic efficacy. About InSite Vision InSite Vision is committed to advancing new and superior ophthalmologic products for unmet eye care needs. InSite Vision is recognized for the discovery and development of novel ocular pharmaceutical products based on its DuraSite® bioadhesive polymer core technology, an innovative platform that extends the duration of drug delivery on the eye's surface, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. By formulating the well-established antibiotic azithromycin in DuraSite, InSite Vision developed the lowest-dosing ocular antibiotic for the treatment of bacterial conjunctivitis (pink eye) available to the United States ophthalmic market, AzaSite® (azithromycin ophthalmic solution) 1%. AzaSite is marketed by Inspire Pharmaceuticals in the United States and Canada and will be marketed by international partners in Japan, South Korea, four countries in South America, Turkey and China upon approval in those countries.

Keywords: Health, Biotechnology, Optical, Asia, Asia, China, Food, Japan, South Korea, Technology, InSite Vision Incorporated.

This article was prepared by China Business Newsweekly editors from staff and other reports. Copyright 2009, China Business Newsweekly via VerticalNews.com.