US-based InSite Vision has released top-line positive results of its Phase III clinical trial of BromSite (ISV-303) for the reduction of inflammation and pain after cataract surgery.
BromSite is a combination of a low dose (0.075%) non-steroidal anti-inflammatory drug (NSAID) bromfenac and InSite Vision’s DuraSite drug delivery technology.
A total of 248 patients undergoing cataract surgery were enrolled in the two-arm BromSite Phase III trial designed to assess the efficacy and safety of BromSite against the DuraSite vehicle alone.
In the trial, patients were randomised and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and for 14 days post-surgery.
In the second trial, BromSite achieved statistically significant superiority compared to vehicle (p=0.01) in alleviating ocular inflammation at day 15 among patients after cataract surgery compared to the vehicle arm.
BromSite also achieved superiority compared with vehicle (p<0.001) for the secondary endpoint of post-surgical reduction in pain, in addition to achieving a third endpoint of reduction in inflammatory flare (p<0.01) that was incorporated into the protocol based on feedback from European regulatory authorities.
The company said that results from Phase III trial of BromSite reflect a modified intent-to-treat population agreed upon with the US Food and Drug Administration (FDA) after the trial was completed.
As part of the modified intent-to-treat protocol, 14 patients enrolled in the trial who did not undergo surgery and complete dosing past Day 1 have been excluded from the efficacy results and analysis.
In the trial, BromSite was well tolerated and no safety concerns or drug-related serious adverse events reported.
Results from the second, confirmatory study of BromSite are similar to those achieved in the company’s first Phase III clinical evaluation of BromSite for the reduction of inflammation and pain following cataract surgery.
BromSite achieved improvements versus vehicle across the primary and secondary endpoints in the company’s first Phase III clinical trial, which 268 patients were enrolled under.
InSite Vision chief medical officer Kamran Hosseini said: "In consultation with the FDA on our BromSite Phase 3 programme, we have modified the intent-to-treat population to include just data from those patients who underwent surgery, thereby more accurately gathering data that pertain to the post-surgical indication.
"We believe we have an excellent working relationship with the FDA and have collaborated closely with the Agency to establish clear endpoints and study protocols for all of our clinical trials.
"We look forward to a pre-NDA meeting with the FDA on 13 January 2014, to discuss the full results of our Phase III clinical trials of BromSite."
The company said that the positive results from its two Phase III studies will provide a solid basis for its planned New Drug Application (NDA) regulatory filing for BromSite in the second half of 2014.
Additionally, InSite also plans to seek regulatory approval for BromSite in Europe.
InSite Vision has contracted Pharm-Olam International for managing the BromSite Phase II clinical studies on behalf of the company.