InSite Vision Incorporated, a company developing ophthalmic products for unmet eye care needs, recently 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, MD, PhD, 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 US for the treatment of post-operative inflammation in patients who have undergone cataract extraction. By combining a lower concentration of bromfenac with DuraSite, InSite Vision’s proven bioadhesive 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.

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.

InSite Vision is committed to advancing new and superior ophthalmologic products for unmet eye care needs. InSite Vision is recognized for the discovery and development of novel ocular pharmaceutical products based on its DuraSite bioadhesive polymer core technology, an innovative platform that extends the duration of drug delivery on the eye’s surface, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. AzaSite is approved in the US and Canada and currently marketed by InSite Vision’s partner, Inspire Pharmaceuticals, in the US. InSite Vision has formed multiple strategic licensing and distribution agreements with qualified partners to market AzaSite in select countries in Asia and South America upon regulatory approval in those regions. Besivance was approved by the US FDA in the second quarter 2009 and is being marketed by Bausch & Lomb and Pfizer Inc. InSite Vision’s ophthalmic product development pipeline also includes ISV-502 and additional product candidates leveraging the company’s core technologies.