InSite Vision Incorporated (OTCBB:INSV), a company developing novel 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® technology.
“Bromfenac and similar topical NSAIDs are regularly used to manage ocular inflammation and pain following cataract surgeries and other procedures; however, we believe there is a significant opportunity to improve on existing products”
The randomized, placebo-controlled Phase 1/2 clinical trial is designed to evaluate the safety, efficacy and pharmacokinetics of ISV-303. Approximately 160 patients will be enrolled in one of four study arms to receive ISV-303 administered once-daily; ISV-303 administered twice-daily; vehicle; or an approved topical anti-inflammatory agent administered twice-daily. Patients will receive drug therapy following an ocular surgery procedure for two weeks, with two-weeks of follow-up. Results will be measured by patient response assessment of pain and overall satisfaction, combined with an objective assessment by the treating physician utilizing ophthalmic tests and diagnostics. While the trial is not designed to achieve statistical significance, results from this study are expected to provide guidance on the design of a Phase 3 clinical program.
"Bromfenac and similar topical NSAIDs are regularly used to manage ocular inflammation and pain following cataract surgeries and other procedures; however, we believe there is a significant opportunity to improve on existing products," said Kamran Hosseini, M.D., Ph.D., Vice President, Clinical Affairs and Chief Medical Officer of InSite Vision. "Leveraging our proven DuraSite technology to extend the duration of drug delivery to the eye, ISV-303 has the potential to offer important advantages in relieving pain and discomfort, as well as improving dosing convenience. We expect to report initial data from this Phase 1/2 clinical study in early 2011 and these results will guide the design of Phase 3 studies, which could begin as early as the second half of 2011."
Cataract surgery is the most frequently performed ocular surgery in the United States, with more than three million procedures in the U.S. each year. Following surgery, anti-inflammatory eye drops are typically prescribed to reduce pain and enhance healing.
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™, 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. 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.
Vitamin K2 reduces the frequency, intensity, and duration of nighttime leg cramps