InSite Vision Incorporated, a company developing ophthalmic therapeutics, today announced the initiation of a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the non-steroidal anti-inflammatory (NSAID) bromfenac with InSite Vision’s proprietary DuraSite(R) technology. The randomized, placebo-controlled Phase 1/2 clinical trial is designed to evaluate the safety, efficacy and pharmacokinetics of ISV-303.

InSite’s DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables 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(R) (azithromycin ophthalmic solution) 1% and Besivance(TM) (besifloxacin ophthalmic suspension) 0.6%.

ISV-303 is intended to extend the duration of drug residence on the eye’s surface to facilitate better penetration and thus reduce dosing, while potentially improving the efficacy profile. ISV-303 combines a low concentration of bromfenac (Xibrom(TM), marketed by ISTA Pharmaceuticals) with DuraSite, InSite Vision’s proven bioadhesive polymer technology. In preclinical studies, ISV-303 demonstrated a superior delivery and ocular distribution profile when compared to the commercially available bromfenac eye drop.

Read ^[1] the full press release on InSite Vision’s website.