Patient enrollment has begun in a phase III clinical trial of a low dose of bromfenac for pain and inflammation reduction after cataract surgery.
Alameda, CA-Patient enrollment has begun in a phase III clinical trial of a low dose of bromfenac delivered via a synthetic polymer-based formulation designed to extend the residence time of a drug (BromSite, InSite Vision) for the reduction of pain and inflammation after cataract surgery.
Researchers in this study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of a low dose (0.075%) of bromfenac delivered via the polymer-based drug delivery system, compared with the polymer-based drug delivery system vehicle (DuraSite, InSite Vision) alone.
The phase III clinical study is a two-arm, double-blind, placebo-controlled clinical trial where the placebo arm will be the polymer-based drug delivery system vehicle. In 15 separate sites, patients undergoing cataract surgery will be randomly assigned and then dosed twice a day beginning the day before surgery and continuing the day of surgery and 14 days post-surgery. The primary study endpoint is the reduction of pain and inflammation after surgery.
“[Bromfenac delivered via the polymer-based drug delivery system] has the potential to improve care significantly for patients undergoing cataract surgery in the rapidly growing eye surgery market,” said Kamran Hosseini, MD, PhD, vice president and chief medical officer of InSite Vision. “We are confident this phase III study will enroll quickly given the positive data obtained in our prior clinical trials of [bromfenac delivered via the polymer-based drug delivery system], including the statistically significant reduction in pain and inflammation achieved in our phase I/II study with the same primary endpoint as this trial.”
Dr. Hosseini said InSite Vision anticipates top-line results from this first phase III study to be available in late 2012 or early 2013. The design of a second phase III study is being finalized.
The proprietary sustained-delivery technology is designed to extend the residence time of a drug relative to conventional topical therapies. For more information, visit www.insitevision.com.
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