InSite Vision Initiates First Phase III Clinical Study

InSite Vision Incorporated recently announced that patient enrollment has begun in the first Phase III clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery. 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 BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite drug delivery technology.

“BromSite has the potential to significantly improve care 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 BromSite, including the statistically significant reduction in pain and inflammation achieved in our Phase I/II study with the same primary endpoint as this trial. We anticipate top-line results from this first Phase III study will be available in late 2012 or early 2013.”

The BromSite Phase III clinical study is a two-arm, double-blind, placebo-controlled clinical trial in which the placebo arm will be the DuraSite vehicle. Using 15 separate sites, patients undergoing cataract surgery will be randomized 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. Pharm-Olam International has been selected to serve as the contract research organization managing the BromSite study on behalf of InSite Vision.

This is the first of two Phase III clinical studies in support of BromSite’s regulatory submissions. In the second quarter of 2012, InSite conducted an end-of-Phase II meeting with the US FDA and two European regulatory meetings, where both BromSite pivotal trials were discussed. The design of the second Phase III study for BromSite will soon be finalized pending full input from both the European regulators and the FDA.

In the Phase I/II study of 169 patients undergoing cataract surgery, once-daily and twice-daily doses of BromSite were compared against the DuraSite vehicle alone. Once-a-day BromSite was demonstrated to be superior to vehicle (53.3% versus 19%, P-value of 0.0016) in reducing pain and inflammation. InSite reported results from the Phase I/II clinical study in March 2011.

In a Phase II clinical study evaluating pharmacokinetics, BromSite achieved more than twice the eye tissue penetration than Bromday (bronfenac ophthalmic solution) 0.09% marketed by ISTA Pharmaceuticals. Results from the Phase II clinical trial comparing BromSite to Bromday were released in October 2011.

Cataract surgery is the most frequently performed ocular surgery in the US with more than 3 million procedures annually. Both before and after surgery, anti-inflammatory eye drops are prescribed to reduce pain and inflammation. Anti-inflammatory eye drops are also administered as prophylaxis against cystoid macular edema, or CME. CME is a relatively rare but extremely serious adverse event in ocular surgery that can lead to blindness. Most physicians believe that a higher penetration of bromfenac into the ocular tissues may reduce the risk of CME. InSite intends to do additional clinical studies post-approval in pursuit of adding prevention of CME to the BromSite label.

InSite’s DuraSite sustained delivery technology is a 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 and Besivance. InSite Vision is advancing a portfolio of novel preclinical-to-clinical-stage ophthalmic products based on the DuraSite platform.

InSite Vision is advancing new ophthalmologic products for unmet eye care needs. The company’s product portfolio utilizes InSite Vision’s proven DuraSite bioadhesive polymer core technology, an innovative platform that extends the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. For more information, visit www.insitevision.com.