InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced that patient enrollment was recently completed in the company's Phase 1/2 clinical trial of ISV-303, a novel compound being developed to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the non-steroidal anti-inflammatory (NSAID) bromfenac (BROMDAY™/Xibrom™ marketed by ISTA Pharmaceuticals) with InSite Vision's proprietary DuraSite® technology.
“We are very pleased by our team's performance on the accelerated rate of enrollment of this Phase 1/2 clinical trial, which was one of the fastest rates on record for a trial of this size and design”
InSite Vision commenced the Phase 1/2 clinical trial in August and enrolled approximately 160 eligible patients undergoing cataract surgery. The study is designed to evaluate the safety and efficacy of ISV-303 when administered either once or twice daily. Patients were randomized into one of four study arms examining ISV-303 as compared to the commercial bromfenac (once or twice daily) or vehicle (e.g., DuraSite). Patient dosing and follow-up for the Phase 1/2 clinical trial is expected to be completed during January, and InSite anticipates announcing top-line results in the first half of 2011. Data from this study are expected to provide guidance on the design of a Phase 3 clinical program. InSite Vision anticipates an additional Phase 2 clinical trial for ISV-303 to investigate, among other things, the pharmacokinetics of ISV-303 in humans.
"We are very pleased by our team's performance on the accelerated rate of enrollment of this Phase 1/2 clinical trial, which was one of the fastest rates on record for a trial of this size and design," said Timothy Ruane, Chief Executive Officer of InSite Vision. "We believe the combination of our DuraSite technology with the approved NSAID bromfenac may create a superior new therapy to improve the outcome of patients undergoing ocular surgery. With an improved efficacy and safety profile, and patent protection extending into 2029, we believe ISV-303 is well positioned to compete in the expanding $300 million ophthalmic NSAID U.S. market."
Based on promising head-to-head preclinical results evaluating ISV-303 versus commercially-available bromfenac, in both single- and multi-use settings, InSite Vision believes ISV-303 has the potential to offer improved efficacy and safety advantages. These head-to-head data have been accepted for publication in a prominent peer-reviewed journal, with publication anticipated in the first quarter of 2011.
Cataract surgery is the most frequently performed ocular surgery in the United States, with more than three million procedures annually. Following surgery, anti-inflammatory eye drops are typically prescribed to reduce pain and inflammation and enhance healing.
ISV-303 is designed to extend the duration of drug residence on the surface of the eye to facilitate better penetration, while potentially improving the efficacy and safety profile, particularly for the prevention of cystoid macular edema. ISV-303 combines a low concentration of bromfenac 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. Further, ISV-303's improved distribution profile was consistent across all ocular tissues, including both the front and back of the eye. InSite Vision is initially developing ISV-303 for use in a post-operative setting to suppress or reduce inflammation and eye pain.
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