Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for Zerviate (OT-1001), a histamine H1 receptor-targeted therapy. This development marks a significant step forward for the company in bringing this innovative treatment to the Chinese market.
Zerviate’s Background and Approvals
Zerviate, originally developed by France-based pharmaceutical firm Nicox SA, is a novel formulation of cetirizine that has already received market approval in the United States. It is recognized as the only ophthalmic antihistamine drug approved by the FDA for use in children aged two years and older, in addition to adults. This makes Zerviate a potentially important treatment option for a wide range of patients in China suffering from ocular allergy symptoms.
Exclusive Rights and Licensing Deal
In March 2019, Nicox SA granted Ocumension exclusive development and commercialization rights for Zerviate in Greater China. This licensing deal was expanded a year later to include 11 countries in Southeast Asia. The agreement underscores the potential of Zerviate in the regional market and Ocumension’s commitment to addressing unmet needs in ophthalmic care.
Conclusion
The acceptance of the NDA for Zerviate by the NMPA is a pivotal moment for Ocumension Therapeutics as it seeks to offer a new treatment option for patients with ocular allergies in China. With its unique formulation and existing approvals in the United States, Zerviate has the potential to significantly improve patient outcomes in the region.-Fineline Info & Tech
