ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB:INSV - News) today 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.
InSite Vision’s ophthalmic product development portfolio also includes ISV-502, which is currently in Phase 3 pivotal trials for the treatment of eye and eyelid infection and inflammation, and additional product candidates leveraging the company’s core technologies. 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 the expected commercial launch date for Besivance, the commercialization status of certain products utilizing the DuraSite technology platform and InSite Vision’s product development and commercial plans. Such statements entail a number of risks and uncertainties, including but not limited to: Bausch & Lomb’s Besivance marketing plans or the timing thereof; InSite’s ability to commence additional clinical trials with respect to ISV-502 and InSite’s various other product candidates and the results of such trials; the clinical results of InSite’s product candidates, including ISV-502; InSite’s reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its products; InSite’s ability to expand its technology 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 and ISV-502; 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, including those with respect to ISV-502. 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.
Contact:
InSite Vision Louis Drapeau, Chief Executive Officer, 510-747-1220 mail@insite.com or Availe Communication Ellen Rose, 650-387-8746 (Media)
