InSite Vision Incorporated (OTCBB: INSV) today introduced DuraSite 2®,
its next-generation enhanced drug delivery system which 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
non-steroidal 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, Ph.D., 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.
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