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InSite Vision Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its next-generation, enhanced drug-delivery system (DuraSite 2) that provides a broad platform for developing topically delivered ocular drugs.
Alameda, CA-InSite Vision Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its next-generation, enhanced drug-delivery system (DuraSite 2) that provides a broad platform for developing topically delivered ocular drugs.
The company reports that the patent is expected to provide protection to the year 2029 for both the delivery system and the drugs formulated with DuraSite 2, both internal pipeline and partnering. The newer drugs are expected to provide enhanced tissue penetration in order to improve efficacy and dosing convenience.
“DuraSite 2 has demonstrated increased drug retention and tissue penetration up to four-fold greater than a commercial ophthalmic pain reliever in preclinical studies,” said Timothy Ruane, chief executive officer of InSite. “Based on its potential to increase efficacy significantly and reduce dosing requirements, we believe DuraSite 2 could serve as a standard drug delivery technology across ophthalmic therapeutics.”
Ruane added that the company plans to utilize the 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 with the same product alone or formulated with InSite’s DuraSite technology. Results of that study showed that the DuraSite 2 formulation achieved more than two times and four times concentrations in the aqueous humor of the eye compared with the DuraSite formulation or marketed drug, respectively. The 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.
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