InSite Vision has submitted ISV-101 investigational new drug (IND) application with the US Food and Drug Administration (FDA) as a treatment for treat dry eye disease.
The company expects to initiate a Phase 1/2 clinical trial to investigate the safety and efficacy of the drug, in 2011.
ISV-101 combines a low dose of the non-steroidal anti-inflammatory (NSAID) bromfenac (Bromday/Xibrom marketed by ISTA Pharmaceuticals) with InSite Vision‘s proprietary DuraSite technology.
InSite Vision said that the initial data from clinical studies evaluating the combination of DuraSite with a higher dose of bromfenac have demonstrated a favorable safety profile.
InSite Vision CEO Timothy Ruane said that with patent protection extending into 2029, they believe ISV-101 can be well positioned to compete in the expanding $500m US dry eye market.