The Dry Eye Zone

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Drug news: InSite Vision submits ISV-101

InSite Vision submits ISV-101 investigational NDA with FDA

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.
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