InSite Vision has finished enrolling more than 240 patients undergoing cataract surgery in the first Phase III clinical trial to assess the safety and efficacy of BromSite (ISV-303) for mitigation of pain and inflammation post-surgery.
Combining the company’s DuraSite drug delivery technology with a low dose (0.075%) of the non-steroidal anti-inflammatory drug bromfenac, BromSite seeks to assess its efficacy as against using DuraSite alone.
The two-arm trial has randomised the patients at 15 separate sites and dosed them twice a day for 15 days, beginning from the day before surgery.
Reduction in pain and inflammation after cataract surgery is the primary endpoint for the study.
InSite Vision vice president and chief medical officer Dr Kamran Hosseini said the company believes that there is significant opportunity to improve care in patients who undergo cataract surgeries.
"Prior clinical trials of BromSite demonstrated superiority over the then market-leader, with twice the tissue penetration using a lower dose of bromfenac due to its formulation in our proprietary DuraSite vehicle," Hosseini said.
"Better tissue penetration should reduce inflammatory symptoms, which are key to preventing post-surgical side effects, in addition to providing longer lasting pain relief to patients."
InSite Vision CEO Timothy Ruane said the company expects the Phase III clinical trial data to be released in early 2013.
"We are finalising our plans for a second Phase III clinical study of BromSite and, pending positive results from both trials, are committed to filing a New Drug Application for BromSite in 2013," Ruane said.
In addition to BromSite, the company is planning to advance Phase III clinical studies for its AzaSite Plus and DexaSite, which are used to treat eye infections.