• Nicox PArtner, occupation therapeutics, announced on April 26, 2023 that they had done so received priority review status for The Nah DCarpet AApplication for ZERVIATE in China
• Accelerates the CERVIATE^® Admission and launchwhich are expected in China in 2024

April 28, 2023 – Release at 7:30am BST
Sophia Antipolis, France

Nicox S.A FR COX))), an international eye care company, announced today that it has received the New Drug Application (NDA) for approval to commercialize ZERVIATE^® (cetirizine ophthalmic solution), 0.24%, submitted in China by its exclusive Chinese partner Ocumension Therapeutics, has been included in the priority review and approval process of the National Medical Products Administration of the People’s Republic of China (“NMPA”). This will speed up the approval process and potentially the launch of ZERVIATE in China.

ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC^®and is currently marketed in the US for eye itching associated with allergic conjunctivitis. The prescription allergic conjunctivitis products market in China is expected to grow to nearly US$500 million by 2030. Ocumension forecasts ZERVIATE’s potential annual net sales of >$100 million within 7 years.

The ZERVIATE NDA in China is supported by the data package licensed from Nicox to Ocumension and an additional Chinese Phase 3 clinical trial of ZERVIATE conducted by Ocumension. ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE®. ZERVIATE emedastine difumarate was found to be non-inferior to the primary efficacy endpoint of change from baseline in pruritus score in the 24 hours prior to the Day 14 visit. ZERVIATE was safe and well tolerated, with no difference in the proportion of patients with adverse events…