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news.InSite Vision, an ophthalmic product development company, has announced that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision's DuraSite patented drug delivery system.
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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, increased patient compliance, and increased efficacy, the company said.
Bausch & Lomb is developing this broad-spectrum, anti-infective drop specifically for ophthalmic use, and receipt of unanimous recommendation by this FDA advisory committee is a key step in the approval review process for a new drug application.
Bausch & Lomb licensed the besifloxacin DuraSite formulation from InSite Vision in 2003 following Phase I clinical studies and continued the development to this new drug application filing. Based on the terms of the agreement, InSite is expected to receive competitive single-digit royalties on sales of the approved product.
Louis Drapeau, CEO of InSite, said: This positive recommendation by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee further demonstrates the clinical value of the DuraSite technology in new products promising valuable approaches to treating common eye care conditions.
This new Bausch & Lomb agent has the potential to be the second approved product incorporating our DuraSite platform. We continue to look for new opportunities to develop pharmaceutical products utilizing this novel technology platform.