Healthcare Industry News:  azithromycin 

Biopharmaceuticals Ophthalmology Regulatory

 News Release - March 31, 2009

InSite Vision Receives Regulatory Approval for AzaSite( )in Canada

ALAMEDA, Calif.--(HSMN NewsFeed)--InSite Vision Incorporated (AMEX:ISV ) today announced that the Therapeutic Products Directorate (TPD) of Health Canada has approved the company’s new drug submission (NDS) for AzaSite (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye) in adults and children one year and older. AzaSite is formulated with DuraSite®, InSite Vision’s patented drug delivery vehicle that enhances the retention time of the antibiotic on the surface of the eye, offering the benefit of a less frequent and more convenient dosing regimen.

AzaSite was approved for treatment of bacterial conjunctivitis by the U.S. Food and Drug Administration (FDA) in April 2007, and commercially launched in August 2007 by Inspire Pharmaceuticals, a biopharmaceutical company based in Durham, North Carolina and exclusive licensee of AzaSite in the U.S. and Canada. Under the terms of the companies’ agreement, the NDS will transfer to Inspire Pharmaceuticals and Inspire will be responsible for marketing AzaSite in Canada.

“Canadian approval of AzaSite is an important milestone for InSite, furthering our efforts to reach more patients with a product that is a clinically proven, safe and effective treatment for conjunctivitis and typically requires less than half the dosing of other ocular antibiotics,” commented Lou Drapeau, InSite’s Chief Executive Officer. “We are focused on supporting our marketing partner, Inspire Pharmaceuticals, on the expansion of AzaSite sales and we look forward to working closely with them to capture additional value for the product throughout North America.”

Canadian regulatory approval was based on two Phase 3 clinical trials of AzaSite which demonstrated that AzaSite was safe and effective. Enrolling more than 1400 patients with bacterial conjunctivitis in the U.S. and Latin America, AzaSite was administered twice daily on the first two days, then once daily on days 3-5. Results from the Phase 3 pivotal trials demonstrated that AzaSite provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared to placebo; and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day for five days.

About Conjunctivitis

Conjunctivitis (pink eye) is an inflammation or infection of the transparent membrane (conjunctiva) lining the eyelid and part of the eyeball. The cause is a bacterial or viral infection and the most common symptoms include redness, itching or a gritty feeling in one or both eyes, and may be accompanied by a discharge or tearing. While anyone can get conjunctivitis, it is very common in children, is highly contagious and has been estimated to account for up to three million missed school days in the United States alone.

About InSite Vision

InSite Vision is committed to advancing new and superior ophthalmic products for unmet eye care needs. InSite 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 developed the lowest-dosing ocular antibiotic available to the United States ophthalmic market, AzaSite® (azithromycin ophthalmic solution) 1%. AzaSite is marketed by Inspire Pharmaceuticals in the United States for the treatment of bacterial conjunctivitis (pink eye) and will be by international partners in South Korea, four countries in South America, Turkey and China.

InSite’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 (blepharoconjunctivitis), 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 marketing of AzaSite Canada by Inspire and InSite’s plans to advance AzaSite and its AzaSite family of products. Such statements entail a number of risks and uncertainties, including but not limited to: InSite’s reliance on third parties, including Inspire, for the commercialization of AzaSite and its other products; InSite’s ability to retain Mr. Drapeau and other key management now and in the future; the ability of InSite to enter into corporate collaborations for AzaSite outside its currently licensed territories, and with respect to its other product candidates, including ISV-502; Inspire’s ability to successfully market AzaSite in the United States and Canada; the ability of InSite’s international partners to obtain approval to market AzaSite outside the U.S. and Canada; InSite’s ability to commence clinical trials with respect to its various product candidates and the results of such trials; the clinical results of InSite’s product candidates; 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; 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.


Source: InSite Vision

Issuer of this News Release is solely responsible for its content.
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