InSite Vision has initiated a Phase I/II clinical trial of ISV-303, a topical anti-inflammatory product intended to relieve the pain and swelling associated with ocular surgery.
ISV-303 combines a low concentration of non-steroidal anti-inflammatory bromfenac with InSite Vision's DuraSite, a bio-adhesive polymer technology, to facilitate better penetration of the drug.
The trial is designed to assess the safety, efficacy and pharmacokinetics of ISV-303. It will involve 160 patients spread across four study arms: ISV-303 administered once-daily; ISV-303 administered twice-daily; approved topical anti-inflammatory agent administered twice-daily or a vehicle.
Participants will receive the drug therapy two weeks after ocular surgery, followed by two weeks of follow-up. Results will be measured by assessing the patient's response to pain and overall satisfaction, along with objective assessment by the treating physician.
The trial results are expected in early 2011 and will guide the design of the Phase III study, which is expected to begin in second half of 2011.