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InSite Vision Inc. has filed with the FDA an investigational new drug (IND) application for a novel compound (ISV-101) for dry eye disease.
Alameda, CA-InSite Vision Inc. has filed an investigational new drug (IND) application with the FDA for a novel compound (ISV-101) for dry eye disease. The compound combines a low dose of the non-steroidal anti-inflammatory bromfenac (Bromday/Xibrom, ISTA Pharmaceuticals) with proprietary sustained delivery technology (DuraSite, InSite Vision).
InSite Vision anticipates beginning a phase I/II clinical trial this year to evaluate the safety and efficacy of the compound when administered twice daily. The five-arm trial design will include three dose concentrations and comparisons against vehicles with and without the sustained delivery technology. Data from the study are expected to provide guidance on the ideal dose for the compound and the design of a phase III 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. “With patent protection extending into 2029, we believe [the compound] can be well positioned to compete in the expanding $500 million U.S. dry eye market.”
The sustained delivery technology, a patented synthetic polymer-based formulation, is designed to extend the duration during which the drug is on the surface of the eye. This extended duration facilitates better penetration, thereby potentially improving efficacy, safety, and dosing of a given therapy. Initial data from clinical studies evaluating the combination of the technology with a higher dose of bromfenac have demonstrated a favorable safety profile, according to InSite, which expects the compound to act as a complementary treatment to cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) for patients with dry eye disease.
The sustained delivery technology platform currently is used in two commercial products, azithromycin ophthalmic solution 1% (AzaSite, Inspire Pharmaceuticals) and besifloxacin ophthalmic suspension 0.6% (Besivance, Bausch + Lomb), for the treatment of bacterial eye infections. InSite Vision also is applying the technology to multiple other clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.