InSite Vision Incorporated announced that it has filed an Investigational New Drug (IND) application for ISV-101 with the U.S. Food and Drug Administration (FDA). ISV-101 is InSite Vision’s novel compound being developed to treat dry eye disease, a widespread condition that is under-treated with currently available medicines. 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 anticipates initiating a Phase 1/2 clinical trial in 2011 to evaluate the safety and efficacy of ISV-101 when administered twice daily to patients suffering from dry eye disease. The five-arm trial design will include three ISV-101 dose concentrations and comparisons against DuraSite and non-DuraSite (placebo) vehicles. Data from the Phase 1/2 study are expected to provide guidance on the ideal dose for ISV-101 and the design of a Phase 3 clinical program.
“I am proud of our team’s ability to expand our clinical development pipeline by advancing this novel new drug candidate for the treatment of dry eye disease,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “Dry eye is a serious chronic condition, and the unique and proven attributes of our DuraSite technology, combined with the approved NSAID bromfenac, are expected to create an effective new therapy that improves the treatment of dry eye disease. With patent protection extending into 2029, we believe ISV-101 can be well positioned to compete in the expanding $500 million U.S. dry eye market.”
Dry eye disease occurs when the eye does not produce sufficient tears. While causes of dry eye may vary, it is frequently associated with inflammation of the surface of the eye, the lacrimal gland, or the conjunctiva. A potentially chronic condition that can occur at any age, dry eye disease is most prevalent among the elderly. It is estimated to affect five million people age 50 and older in the U.S. alone.
ISV-101 incorporates a low concentration of bromfenac with InSite Vision’s proven DuraSite polymer technology. DuraSite extends the duration of drug residence on the surface of the eye to facilitate better penetration, thereby potentially improving efficacy, safety and dosing of a given therapeutic. Initial data from clinical studies evaluating the combination of DuraSite with a higher dose of bromfenac have demonstrated a favorable safety profile. Due to its distinct mode of action, ISV-101 is expected to act as a complimentary treatment to Restasis (marketed by Allergan, Inc.) for patients with dry eye disease. Restasis is currently the largest selling dry eye treatment in the United States for patients with chronic dry eye.
Date: January 11, 2011
Source: InSite Vision Incorporated
Filed Under: Drug Discovery