The United States Patent and Trademark Office (USPTO) has issued key patent No. 8,501,800 to the InSite Vision Inc.’s DuraSite 2 next-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.

This patent will provide utility/ composition of matter protection to 2029 for both the delivery system and the drugs that are formulated with DuraSite 2.

“DuraSite 2 has the potential to significantly increase efficacy and reduce dosing requirements for topically delivered ophthalmic drugs. Based on its ability to significantly improve drug retention and penetration into the tissues of the eye, we believe DuraSite 2 could serve as a standard drug delivery technology across ophthalmic therapeutics,” said Timothy Ruane, CEO of InSite Vision. “We plan to utilize the DuraSite 2 platform in the development of all future InSite Vision pipeline products and seek partners via licensing agreements.”

In a large-scale, preclinical 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 Vision’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 as compared to the DuraSite formulation or marketed drug, respectively. The robust results of this study suggests 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.

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 Vision’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.

InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite platform technologies.