InSite Vision Receives Notice of Allowance from USPTO for Patent on DuraSite®2 Ophthalmic Drug Delivery System
New Therapeutics Formulated in Novel Platform Technology Expected to Have Patent Protection to 2029 for Internal Pipeline and Partnering
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB: INSV) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on its DuraSite® 2next-generation enhanced drug delivery system. DuraSite 2 provides a broad platform for developing topically delivered ocular drugs with enhanced tissue penetration in order to improve efficacy and dosing convenience. The patent is expected to provide protection to 2029 for both the delivery system and the drugs that are formulated with DuraSite 2.
"DuraSite 2 has demonstrated increased drug retention and tissue penetration up to four-fold greater than a commercial ophthalmic pain reliever in preclinical studies. Based on its potential to significantly increase efficacy and reduce dosing requirements, we believe DuraSite 2 could serve as a standard drug delivery technology across ophthalmic therapeutics," said Timothy Ruane, Chief Executive Officer of InSite Vision. "We plan to utilize the DuraSite 2 platform in the development of all future pipeline products. Additionally, once the patent issues, InSite plans to initiate a broad licensing program that provides access to industry partners through both exclusive and non-exclusive licensing and/or commercialization agreements."
In a large-scale comparative study, a drug formulated with DuraSite 2 demonstrated significantly enhanced retention on the eye and tissue penetration as compared to the same product alone or formulated with InSite's DuraSite® technology. Results of that study showed that the DuraSite 2 formulation achieved more than 2x and 4x concentrations in the aqueous humor of the eye compared to the DuraSite formulation or marketed drug, respectively. The robust results of this study suggest that DuraSite 2's increased tissue penetration may enable it to be used in the treatment of back-of-the-eye diseases with a topical eye drop when formulated with drugs that must currently be administered by injection. InSite presented detailed data from this study at the Association for Research in Vision and Ophthalmology (ARVO) 2013 Annual Meeting. The ARVO poster presentation is available in the publications section of InSite Vision's website at www.insitevision.com/publications.
About DuraSite®and DuraSite®2
While eye drops are a proven delivery mechanism for numerous ocular drugs, the efficacy of these agents is impeded by tears and blinking, which rinse the drug from the surface of the eye and limit retention and absorption. InSite's DuraSite and DuraSite 2 platforms are sustained delivery technologies using a synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. DuraSite and DuraSite 2 enable topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® and Besivance®. InSite Vision is advancing a portfolio of novel preclinical- to clinical-stage ophthalmic products based on the DuraSite platform and anticipates advancing future ophthalmic product candidates using the DuraSite 2 platform.
About InSite Vision
InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite® platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs.
The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ and DexaSite™ for the treatment of eye inflammation, and BromSite™ for pain and inflammation associated with ocular surgery. For further information on InSite Vision, please visit www.insitevision.com.
This news release contains certain statements of a forward looking nature relating to future events, including InSite's planned use of DuraSite 2 to formulate future drug candidates; the expected duration of patent protection until 2029, InSite's plans to license DuraSite 2 to third parties, and the expected benefits of the DuraSite 2 drug delivery system. Such statements entail a number of risks and uncertainties, including but not limited to: the ability to formulate DuraSite 2 with existing drugs; that the results of future clinical trials for product candidates formulated in DuraSite 2 may not meet InSite's clinical endpoints or match the results achieved in prior clinical trials; InSite's ability to obtain FDA approval of DuraSite 2 enabled drugs; InSite's ability to successfully license DuraSite 2 to third parties; the risk that DuraSite 2 may not be commercially accepted; the risk that the DuraSite 2 patent could be invalidated or challenged by the USPTO or others or that its duration could be truncated; InSite's reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates; InSite's ability to expand its product 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, 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. 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.
AzaSite®, DuraSite® 2 and DuraSite® are registered trademarks of InSite Vision Incorporated.
AzaSite Plus™, BromSite™ and DexaSite™ are trademarks of InSite Vision Incorporated.
BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.
Louis Drapeau, 510-747-1220
Chief Financial Officer
Media and Investor Inquiries:
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509
KEYWORDS: United States North America California
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