Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that its histamine H1 receptor-targeted drug, Zerviate (OT-1001), has been granted priority review status by the National Medical Products Administration (NMPA).
Zerviate’s Origins and Market Presence
Zerviate, originally developed by France-based pharmaceutical firm Nicox SA, is an innovative formulation of cetirizine that has already received market approval in the United States. In March 2019, Nicox entered into a licensing agreement with Ocumension, granting the company exclusive rights to develop and commercialize Zerviate in Greater China. This agreement was expanded a year later to include 11 additional countries in Southeast Asia. The New Drug Application (NDA) for Zerviate was accepted for review by the NMPA earlier this month.
Implications of Priority Review Status
The priority review status signifies that the NMPA recognizes the potential importance of Zerviate in addressing unmet medical needs in the field of ophthalmology. This designation is expected to expedite the review process, potentially leading to a faster market availability of the drug in China.-Fineline Info & Tech
