Nicox SA provides an update on the approvals and launches of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide by Nicox to Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. As of December 31, 2021, VYZULTA was commercialized in 7 territories: United States (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), Taiwan (2021) and Ukraine (2021). VYZULTA is also approved in 9 other countries, namely Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey and United Arab Emirates. VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States.

Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities. Latanoprostene bunod, the active pharmaceutical ingredient in VYZULTA, was invented and patented by Nicox and was licensed to Bausch + Lomb in 2010. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA and is entitled to receive a $20 million milestone payment1 upon VYZULTA net sales reaching $100 million.

Nicox maintains the patents for latanoprostene bunod, and the U. S. Patent and Trademark Office recently determined that three U.S. composition of matter patents covering latanoprostene bunod are eligible for patent term extension, potentially through to 2030.