MediLexicon News - InSite Vision Announces FDA Approval Of New Ophthalmic Product Enabled By InSite's DuraSite® Technology

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InSite Vision Announces FDA Approval Of New Ophthalmic Product Enabled By InSite's DuraSite® Technology

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 04 Jun 2009

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.

Source
InSite Vision

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InSite Vision Announces FDA Approval Of New Ophthalmic Product Enabled By InSite's DuraSite® Technology

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