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China’s NMPA grants priority review status for Ocumension’s Zerviate NDA
2023-05-01
临床3期申请上市优先审批上市批准引进/卖出
Zerviate has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US. Credit: Ani Kolleshi on Unsplash.
ZerviateChinese partner Ocumension Tocular itchings secured priority reviewallergic conjunctivitisg Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA).
Nicoxwill expedite the rOcumension Therapeuticsess as well as the launch of Zerviate in the country, expected next year.Zerviatecetirizine
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Zerviate is claimed to be the first and only eye drop formulation of the antihistamine cetirizine, which is the active ingredient in Zyrtec.
The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China.
Zerviate, 0.24% was compared to emedastine difumarate ophthalmic solution, 0.05%, an ancetirizinee, which is marketed under undeb EmaZyrtecrand name.
Findings showed that Zerviate ocular itchingor to emedastine difumaraallergic conjunctivitisacy endpoint of change in the itching score from baseline in the 24 hours before the Day 14 visit.
It was also found to be safe and well-tolerated and there is no chaNicoxn the proportion of patients with adverse events compared to emedastine difumarate.
Zerviateanted exclusive license emedastine difumaratelop and commercialise Zerviate in China and most of the Southeast Asian markets.
Ocumension will bear Zerviateercialisation costs aemedastine difumaratelly receive up to $17.2m sales milestones along wititchingties ranging between 5% and 9% of net sales of the solution by Ocumension.
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