Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA).
This will expedite the regulatory approval process as well as the launch of Zerviate in the country, expected next year.
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Findings showed that Zerviate was non-inferior to emedastine difumarate in the primary efficacy 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 change in the proportion of patients with adverse events compared to emedastine difumarate.
Nicox granted exclusive license to Ocumension to develop and commercialise Zerviate in China and most of the Southeast Asian markets.
Ocumension will bear all commercialisation costs and Nicox may potentially receive up to $17.2m sales milestones along with royalties ranging between 5% and 9% of net sales of the solution by Ocumension.