InSite Vision Announces License Agreement
InSite Vision Incorporated recently announced that it has entered into a license agreement with Nicox S.A., a France-based publicly traded company, for the development and commercialization of InSite’s innovative ophthalmic therapeutic products AzaSite (1% azithromycin), AzaSite Xtra (2% azithromycin) and BromSite (0.075% bromfenac) all formulated in InSite’s DuraSite drug delivery system. The agreement grants Nicox exclusive rights to commercialize all three products in Europe (including Eastern Europe), Middle East, and Africa (EMEA). Nicox expects to file European Marketing Authorizations (MAAs) for AzaSite and BromSite by first quarter 2016 with first commercial launch in late 2017.
AzaSite is approved in the US and Canada for the treatment of bacterial conjunctivitis, and is marketed in the US by Akorn, Inc. BromSite is being developed for the treatment of inflammation and prevention of pain after cataract surgery. Based on positive data from two pivotal Phase III clinical studies, InSite intends to file a New Drug Application (NDA) with the US FDA for BromSite in the first quarter of 2015. Nicox is planning to target the same ophthalmic indications in EMEA territories for AzaSite and BromSite. These products will compete in a market estimated to be more than $337 million.
InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs. For more information, visit www.insitevision.com.
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