Nicox SA announced positive results in a Chinese Phase 3 clinical trial of ZERVIATE® (cetirizine ophthalmic solution), 0.24%, run by its Chinese partner, Ocumension Therapeutics. ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE®. ZERVIATE was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching 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 compared to emedastine difumarate. This clinical trial is required for Ocumension to be able to submit a New Drug Application (NDA) for approval to commercialize ZERVIATE in China. Clinical Trial Design: This was a randomized, observer-masked, Phase 3 clinical trial to evaluate the safety and efficacy of ZERVIATE (cetirizine ophthalmic solution), 0.24% dosed twice daily compared to emedastine difumarate ophthalmic solution, 0.05% dosed twice daily in Chinese patients with allergic conjunctivitis.

The treatment period was 14 days and the primary efficacy endpoint was a non-inferiority analysis of the change from baseline in the itching score within the 24 hours prior to the Day 14 visit. A total of 296 patients were randomized across multiple clinical sites in China. ZERVIATE Partnerships: ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets.

Nicox may potentially receive sales milestones of up to USD 17.2 million together with royalties of between 5% and 9% of net sales of ZERVIATE by Ocumension. ZERVIATE is commercialized in the U.S. by exclusive U.S. partner Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical Co. Ltd. of Japan, and is also exclusively licensed to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets, and to Laboratorios Grin in Mexico.