Ocumension Therapeutics Submits a New Drug Application for Zerviate in China
Nicox SA announced that its exclusive Chinese partner, Ocumension Therapeutics, has submitted a new drug application (NDA) seeking approval for commercialization of Zerviate (cetirizine ophthalmic solution), 0.24%, in China.
The intended use of Zerviate is for the treatment of ocular itching associated with allergic conjunctivitis. The approval process is expected to take approximately 12 months, with a potential launch of Zerviate in China anticipated in 2024. Ocumension plans to manufacture Zerviate in their newly built state-of-the-art manufacturing facility located in Suzhou, China.
“Ocumension is a strong partner for Nicox, and we are pleased to see the submission of this new drug application, following the completion of an additional Chinese phase 3 trial carried out by Ocumension. Alongside a broad portfolio of ophthalmology assets in development, Ocumension has also built a commercial operation in China, which will be able to add Zerviate directly into their detailing activities upon approval,” Gavin Spencer, Chief Business Officer of Nicox, said in a company news release. “The approval and launch of Zerviate in 2024 would add another royalty revenue stream to Nicox, onpotential annual net sales which Ocumension forecasts will be over $100 million within 7 years in China. We look forward to Ocumension also expanding the availability of Zerviate to the other Southeast Asian markets they have rights to.”
Zerviate, the first and only eye drop formulation of cetirizine and the active ingredient in Zyrtec, is currently being commercialized in the U.S. for the treatment of ocular itching associated with allergic conjunctivitis. Nicox has projected that the prescription market for allergic conjunctivitis products in China will reach nearly $500 million by 2030.
The new drug application (NDA) for Zerviate in China is supported by the data package licensed by Nicox to Ocumension, as well as an additional phase 3 clinical trial of Zerviate conducted by Ocumension in China. In this trial, Zerviate was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed as Emadine.
The study found that Zerviate was noninferior to emedastine difumarate in terms of the primary efficacy endpoint, which was the change from baseline in the itching score in the 24 hours prior to the Day 14 visit. Zerviate was also found to be safe and well-tolerated, with no significant difference in the proportion of patients experiencing adverse events compared to emedastine difumarate.
Zerviate has been exclusively licensed to Ocumension Therapeutics for its development and commercialization in the Chinese and majority of the Southeast Asian markets. All costs associated with commercialization are the responsibility of Ocumension, while Nicox stands to potentially receive sales milestones of up to US $17.2 million, along with royalties ranging from 5% to 9% of net sales of Zerviate by Ocumension.
