Ocumension Therapeutics Receives Priority Review Status for Zerviate New Drug Application in China
Nicox SA announced that 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 National Medical Products Administration of the People’s Republic of China (NMPA). This will accelerate 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 commercialized in the US for ocular itching associated with allergic conjunctivitis. The prescription market for allergic conjunctivitis products in China is expected to grow to almost $500 million by 2030. Ocumension is forecasting potential annual net sales of Zerviate >$100 million within 7 years.
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. Zerviate was found to be noninferior 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.
The priority review and approval process of NMPA is designed to expedite the approval of drugs that address unmet medical needs or have the potential to offer significant improvements over existing treatment options. The inclusion of Zerviate in the priority review and approval process of NMPA will accelerate the review and approval process of its new drug application, which is an important step towards commercialization of Zerviate.
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 $17.2 million together with royalties of between 5% and 9% of net sales of Zerviate by Ocumension.