InSite Vision Incorporated (OTCBB:INSV) today announced that it has entered into a license agreement with Nicox S.A. (NYSE Euronext Paris: COX), 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.

“As Nicox is an emerging international ophthalmology company with an established commercial infrastructure in the main European markets, as well as a growing network of international distributors, we believe Nicox is the right strategic partner to accelerate the commercialization of our DuraSite-based products,” said Timothy Ruane, InSite Vision’s Chief Executive Officer. “This agreement allows us to bring our innovative products addressing significant eye care needs for patients in a large part of the globe.”

Under terms of the licensing agreement, InSite will receive an upfront payment of $3 million and potentially $13.75 million in milestone payments. Upon product launch, InSite will also receive tiered, mid-single digit to double-digit royalties.

AzaSite is approved in the United States and Canada for the treatment of bacterial conjunctivitis, and is marketed in the U.S. 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 3 clinical studies, InSite intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration 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.

The companies are evaluating the most appropriate indication and development path for AzaSite Xtra, which has completed its pre-clinical testing program in the U.S.

Nicox will manage the further development required for registration of AzaSite and BromSite in the EMEA. No further clinical studies are expected to be required prior to filing MAAs for these products in Europe. A joint collaboration and development committee will oversee the development activities. The companies may collaborate on developing additional indications for the products.

About InSite Vision

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.

The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Akorn, Inc., and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International. InSite Vision is also advancing AzaSite Plus™, a novel ophthalmic therapeutics through Phase 3 clinical studies for the treatment of eye infections, and is preparing two new drug applications (NDA) for the commercial approval by the U.S. Food and Drug Administration (FDA): BromSite™ for the treatment of inflammation and prevention of pain associated with cataract surgery and DexaSite™ for the treatment of blepharitis. For further information on InSite Vision, please visit www.insitevision.com.

Forward-looking Statements

This news release contains certain statements of a forward-looking nature relating to future events, including the timing and likelihood of filing of an MAA for AzaSite in the European Union and an NDA and MAA for BromSite in the United States and the European Union, respectively; that European regulatory authorities may require further studies or additional information prior to filing MAAs or may not approve such MAAs, the expected timing of commercialization of AzaSite and BromSite in Europe; the potential market size for AzaSite and BromSite in Europe; the Company’s current plans to pursue regulatory approval for its product candidates; and the potential indications for the Company’s pipeline drug candidates. Such statements entail a number of risks and uncertainties, including but not limited to: the Company’s ability to obtain substantial additional funding; the ability of the Company to file and receive approval for its BromSite NDA; and for Nicox to file and receive approval of MAAs in Europe and the timing thereof; the Company’s reliance on Nicox to perform its obligations under the license agreement and to successfully develop, obtain approval for, and commercialize AzaSite and BromSite; that the Company may not receive any milestone payments or royalties under the license agreement; the ability of the Company to enter into corporate collaborations for its product candidates; the Company’s ability to expand its product platform including AzaSite Xtra; the Company’s ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; the Company’s ability to maintain and develop additional collaborations and commercial agreements with corporate partners; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Reference is made to the discussion of these and other risk factors detailed in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to the Company, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update any forward-looking information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not unduly rely on such statements or information nor assume that the information provided in this release is still valid at any later date.

AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.
AzaSite Plus™, BromSite™, DexaSite™ and BromDex™ are trademarks of InSite Vision Incorporated.
Besivance® is a registered trademark of Bausch + Lomb Incorporated.