French opthalmic company Nicox SA announced earlier this week that it has signed a licensing agreement with InSite Vision, Inc. for the development, manufacturing and commercialization of the latter’s novel eye treatments, namely: AzaSite (1% azithromycin), BromSite (0.075% bromfenac) and AzaSite Xtra (2% azithromycin). All three products were developed using the company’s proprietary Durasite drug delivery technology, specially designed to maximize the drug’s duration once administered in the eye.
The agreement makes InSite eligible for an upfront payment worth $3 million, and upcoming regulatory and commercial milestone payments, estimated to amount to $13.75 million. Nicox SA’s report disclosed that the agreement’s financial provisions include tiered, mid-single-digit to double digit royalties.
Nicox will gain exclusive rights to the three opthalmic drugs in Europe, the Middle East, and Africa, with pending European Marketing Authorization applications for AzaSite and BromSite, expected to be filed within Q1 2016, and hopefully, launched towards the end of 2017 in a market estimated to be worth over EUR 267 million. To lead up to this, Nicoz will be funding and overseeing these products’ further development, to ensure a smoother and quicker registration process in the three mentioned territories.
Tim Ruane, Chief Executive Officer of InSite Vision, said, “As an emerging international ophthalmology company with an established operational 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 and realize the full potential of our Durasite-based products.”
Today, AzaSite is approved in the United States and in Canada as a treatment for bacterial conjunctivitis, and is marketed under InSite licensee, Akorn, Inc. Additionally, BromSite is indicated for the treatment of inflammation and post-operative pain after cataract surgery. Based on encouraging findings from a pair of pivotal Phase III clinical tests, InSite plans to file a New Drug Application with the US Food and Drug Administration for BromSite, expected in Q1 2015. No further clinical studies are expected to be required prior to filing for AzaSite and BromSite.
In other news on cataract research and development, in a recent study entitled “Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial,” a team of researchers described the aim and methodology of a future trial to investigate the impact of cataract surgery on patients’ circadian rhythm disorders. The authors hypothesize that cataract surgery, by increasing light transmission to cataract affected patients, will correct their circadian rhythm and prevent its associated health problems.
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