InSite Vision Incorporated (OTCBB: INSV), a company developing ophthalmic products for unmet eye care needs, announced plans to advance new development candidate ISV-303, a topical anti-inflammatory product intended to reduce the pain and swelling associated with ocular surgery. InSite Vision formulated a lower concentration of bromfenac with its proprietary DuraSite® technology to create a proprietary therapeutic product. InSite Vision intends to advance ISV-303 into clinical studies pending the completion of Investigational New Drug-enabling toxicology studies in the first half of 2010.

“ISV-303 uses a lower concentration of an approved product and combines it with a commercially-proven technology to create a promising therapeutic that we believe will offer significant safety, efficacy and dosing advantages,” said Kamran Hosseini, M.D., Ph.D., Chief Medical Officer and Vice President, Clinical Affairs. “Our DuraSite platform offers a number of therapeutic advantages, as has been demonstrated in two commercial products, AzaSite and Besivance, which leverage this technology. In preclinical studies, ISV-303 appears to offer compelling benefits that we hope will translate into an improved, easy-to-use eye drop to alleviate the pain and swelling associated with cataract surgery. We look forward to advancing this new development candidate into clinical trials next year.”

Bromfenac (Xibrom™, marketed by ISTA Pharmaceuticals) is a topical non-steroidal anti-inflammatory product approved in the U.S. for the treatment of postoperative inflammation in patients who have undergone cataract extraction. By combining a lower concentration of bromfenac with DuraSite, InSite Vision’s proven bio-adhesive polymer technology, ISV-303 is intended to extend the duration of drug residence on the eye’s surface to facilitate better penetration and thus reduce dosing, while potentially improving both efficacy and side effect profiles. In preclinical studies to date, ISV-303 demonstrated a superior delivery and ocular distribution profile when compared to the commercially available product. Further, ISV-303’s improved distribution profile was consistent across all ocular tissues, including both the front and back of the eye. InSite Vision plans to present data from its preclinical studies at an upcoming scientific meeting.

About DuraSite

InSite’s DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1% and Besivance™ (besifloxacin ophthalmic suspension) 0.6%. InSite vision is also applying DuraSite to clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.

Source
InSite Vision