Nicox SA announced that its exclusive Chinese partner, Ocumension Therapeutics, has submitted a New Drug Application (NDA) for approval to commercialize ZERVIATE(R) (cetirizine ophthalmic solution), 0.24%, in China, for ocular itching associated with allergic conjunctivitis. The approval process is expected to take around 12 months, leading to a potential launch of ZERVIATE in China in 2024. Ocumension plans to manufacture ZERVIATE in their new purpose-built manufacturing facility located in Suzhou, China.

ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC(R), and is currently commercialized in the U.S. for ocular itching associated with allergy conjunctivitis. The prescription market for allergic conjunctivitis products in China is expected to grow to almost USD 500 million by 2030. The ZERVIATE NDA in China is supported by the data package licensed by Nicox to Ocumension and an additional Chinese Phase 3 clinical trial of ZERVIATE run by Ocumension.

ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE(R). 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.

ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets. All costs of commercialization are borne by Ocumension and 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.