ZERVIATE APPROVATO.
Press Release
Nicox receives FDA approval of ZERVIATE (cetirizine ophthalmic solution) 0.24%
- First approved US NDA for Nicox
- First topical ocular formulation of the antihistamine cetirizine
- U.S. patent protection until at least 2030
- Partnering discussions underway for U.S. commercialization rights
May 31, 2017 - release at 3:00 pm CET
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ZERVIATE (cetirizine ophthalmic solution 0.24%; formerly AC-170) the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis.
“Receiving approval from the U.S. FDA for ZERVIATE is a huge milestone for Nicox and partnering discussions are underway for U.S. commercialization rights,” commented Michele Garufi, Chairman and Chief Executive Officer of Nicox.
“We expect to further solidify our position as a leading ophthalmic R&D company with the anticipated FDA decision on Vyzulta, which is licensed worldwide to Bausch + Lomb, and the expected commencement of Phase 2 clinical trials for both NCX 4251 and NCX 470. This is an exciting time for Nicox, and we look forward to keeping you updated on our progress.”
Following discussion with the AMF, the Company has requested the suspension of trading in Nicox shares today, Wednesday May 31, 2017. Trading is expected to recommence shortly after the issuance of this press release
Please find attached the complete press release
About Nicox
Nicox is an international ophthalmic R&D company utilizing innovative science to maintain vision and improve ocular health. By leveraging its proprietary expertise in nitric oxide donation and other technologies, the Company is developing an extensive portfolio of novel therapies that target multiple ophthalmic conditions, including glaucoma. Nicox currently has an approved NDA product and another product at the pre-approval stage with the U.S. Food and Drug Administration (FDA) and a promising pipeline including next-generation stand-alone nitric-oxide donors, with the potential to treat a range of ophthalmic indications. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit:
www.nicox.com .