December 20, 2007
InSite Vision Initiates Pivotal Phase 3 Trials for AzaSite Plus(TM)
InSite Vision (AMEX:ISV) announced today that it has initiated pivotal Phase 3 clinical trials to evaluate AzaSite Plus™ for the treatment of blepharoconjunctivitis, a frequently-chronic inflammation of the conjunctiva and eye lids caused by infections or allergic reactions. AzaSite Plus, formulated in InSite's patented DuraSiteÃ® sustained delivery vehicle, is a topical combination antibiotic/corticosteroid product that is being developed to provide simultaneous antimicrobial and anti-inflammatory treatments.
"The initiation of Phase 3 trials for AzaSite Plus is a significant accomplishment for InSite Vision. AzaSite Plus will potentially expand our product portfolio toward providing effective and differentiated alternatives in the treatment of acute and chronic ocular infection and inflammation," said S. Kumar Chandrasekaran, President and Chief Executive Officer. "Blepharoconjunctivitis is a disease with no approved drug therapy indicated for the relief of its chronic symptoms. We look forward to meeting the challenge of bringing a new therapeutic combination product through the regulatory process."The Phase 3 pivotal trials will test a total of approximately 800 patients. The dosing regimen consists of one drop in the eye and one on the eyelid, two times a day for 14 days. There are three treatment arms with the objective that AzaSite Plus will show superiority in treating blepharoconjunctivitis over AzaSiteÃ® (azithromycin ophthalmic solution) 1% -- InSite's topical anti-infective drug on the market to treat bacterial conjunctivitis (pink eye) -- and superiority over dexamethasone. The end-points required for product approval include lid margin redness, lid swelling, conjunctival redness, ocular discharge, and discomfort symptoms.
Results from a Phase 1 trial and a subsequent Pilot Study led to the design of the Phase 3 trials and the selection of end-points. The Phase 1 clinical study was intended to evaluate both the safety and tolerability of the AzaSite Plus formulation in normal volunteers. The trial enrolled 46 subjects with ages ranging from 19 to 67 years. Trial participants received eye drops of either placebo or AzaSite Plus two times daily for 14 days. Safety data showed that the product was well tolerated and no serious adverse events were reported. Treatment-related ocular adverse events were minimal in frequency and equivalent between the two groups. There were no significant differences in intraocular pressure between the AzaSite Plus group and placebo group after 14 days of treatment.
The Pilot Study was designed to evaluate end-points and time points for use in the Phase 3 trials. There were 32 patients with blepharoconjunctivitis who completed the double-masked and randomized trial and received eye drops two times a day for 14 days. The results led to the selection of end-points for the Phase 3 studies.
About AzaSite Plus
AzaSite Plus combines 1.0% azithromycin and 0.1% dexamethasone in DuraSite, which is InSite Vision's sustained drug delivery system for topical indications. It provides the broad anti-bacterial coverage of InSite Vision's AzaSite product which is currently on the market for the treatment of bacterial conjunctivitis. AzaSite Plus will be indicated for blepharoconjunctivitis, in which simultaneous antimicrobial and anti-inflammatory treatments are required. Both AzaSite Plus, like AzaSite, is designed to achieve high tissue levels of drug with reduced dosing frequency when compared with currently available forms of treatment.
InSite's DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates.
Blepharoconjunctivitis is a frequently recurring disease with inflammation of the conjunctiva and eye lids caused by infections or allergic reactions. The typical treatment is eye hygiene using lid scrubs, topical and/or systemic antibiotics, and topical corticosteroids.
About InSite Vision
InSite Vision develops novel topical anti-infective products, including AzaSite (azithromycin ophthalmic solution) 1% which was launched in the United States by Inspire Pharmaceuticals for the topical treatment of bacterial conjunctivitis (pink eye). Based on its proprietary azithromycin-DuraSite technology platform, InSite is pursuing the expansion of its portfolio of anti-infective ophthalmic products to include AzaSite Plus™ and AzaSite Xtra™ whose product features have the potential to provide significant advantages currently not available with conventional treatment options. In addition, InSite is evaluating the use of its azithromycin-DuraSite platform to develop topical anti-infective products outside of the market category of ophthalmology beginning with AzaSite Otic™ for ear infections.
Forward Looking Statements
This news release contains certain statements of a forward-looking nature relating to future events, such as the expected size, structure, objectives and end-points of the AzaSite Plus Phase 3 trials; the expected benefits of and indications for AzaSite Plus; InSite's expected development and commercialization of additional anti-infective therapies using its DuraSite sustained delivery technology; InSite's corporate goals; and the proposed indications and clinical status of the company's other product candidates. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to fully enroll, conduct and complete a successful Phase 3 trial of AzaSite Plus; the risk that the results of the AzaSite Phase 3 trials will not meet the expected end-points or that significant side effects may be encountered; InSite Vision's ability to obtain additional funding to continue its operations; its reliance on third parties, including Inspire, for the commercialization of AzaSite and its other products; the ability of InSite Vision to enter into a corporate collaboration for AzaSite outside the U.S. and Canada and with respect to its other product candidates, including AzaSite Plus; Inspire's ability to successfully market AzaSite in the United States and Canada; the clinical results of InSite's product candidates; InSite Vision's ability to expand its technology platform to include additional indications; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite, AzaSite Plus, AzaSite Xtra and AzaSite Otic; and 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 AzaSite Plus and AzaSite Otic. 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.