InSite Vision Introduces DuraSite 2

InSite Vision Incorporated recently introduced DuraSite 2, its next-generation enhanced drug delivery system that provides a broad platform for developing superior ophthalmic therapeutics. DuraSite 2 increases the tissue penetration for topically delivered ocular drugs with the aim of improved efficacy and dosing convenience.

The company also announced topline data from a large-scale comparative study that demonstrates superior drug retention and tissue penetration for DuraSite 2 as compared to DuraSite. DuraSite 2 is based on InSite’s proven original DuraSite technology, and incorporates a cationic polymer to achieve sustained and enhanced ocular delivery of drugs. InSite scientists formulated both DuraSite 2 and DuraSite with the commonly used cataract surgery drug, ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), and conducted experiments to evaluate the difference between the two delivery systems and the commercially available ketorolac solution.

InSite recently completed a three-arm preclinical pharmacokinetic study comparing DuraSite 2 versus DuraSite versus ketorolac in an industry-standard animal model. Results of this study show that the DuraSite 2 formulations of ketorolac demonstrated significantly higher drug levels than DuraSite plus ketorolac, or ketorolac alone, achieving more than 2x and 4x concentrations in the aqueous humor of the eye, respectively. Further, there was no indication of eye irritation using the DuraSite 2 formulation. InSite plans to submit detailed data from this study for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2013 Annual Meeting.

“With DuraSite 2, we have developed a powerful new ophthalmic drug delivery platform that improves upon our well-established DuraSite technology and has surpassed our expectations, achieving multifold tissue penetration and positive safety results in a well-designed, large-scale preclinical study,” said Lyle Bowman, PhD, Vice President of Development of InSite Vision. “InSite scientists have unique expertise in formulating novel ophthalmic therapeutics, and we believe DuraSite 2 could be critical in optimizing the profile of approved and future ocular drugs, extending the drug retention on the eye and reducing dosing frequency and the amount of drug needed to achieve efficacious results. In addition to these potential clinical advantages, the intellectual property surrounding DuraSite 2 was filed in early 2009, providing potential patent life into 2029 for this new drug delivery system, as well as increased protection for all drugs formulated with DuraSite 2.”

DuraSite 2 patent applications were submitted in 2009 in the United States and Europe and published in 2010. Both patents are pending issuance. InSite Vision plans to utilize the DuraSite 2 platform in all future pipeline product candidates. Additionally, InSite will be finalizing and announcing a broad and novel licensing program with the intent of making DuraSite 2 a standard drug delivery technology in the ophthalmology industry, and provide access to industry partners through both exclusive and non-exclusive licensing and/or commercialization agreements.

While eye drops are a proven delivery mechanism for numerous ocular drugs, 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. For more information, please visit www.insitevision.com.