Ocumension Obtains Positive Phase 3 Clinical Trial Results for Zerviate in China
Nicox announced positive results in a Chinese phase 3 clinical trial of Zerviate(cetirizine ophthalmic solution), 0.24%, run by its partner, Ocumension Therapeutics.
Zerviate was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name Emadine. Zerviate was found to be noninferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. Zerviate was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate. This clinical trial is required for Ocumension to be able to submit a new drug application (NDA) for approval to commercialize Zerviate in China.
“The successful completion of this clinical trial is an important step towards commercialization of Zerviate in China and we congratulate our partner, Ocumension, on its swift execution. Ocumension is able to use Nicox’s data previously generated on Zerviate in the United States, supplemented with this clinical trial, to support their application for approval of Zerviate,” Gavin Spencer, Chief Business Officer of Nicox, said in a company news release. “We look forward to seeing Zerviate on the market in China, as well as the territories in the Far East where Ocumension has licensed the rights, and we continue to collaborate with our other partners to obtain approval for Zerviate in multiple geographies.”
Zerviate is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in Zyrtec, and is currently commercialized in the US for ocular itching associated with allergic conjunctivitis. The prescription market for allergic conjunctivitis products in China is expected to grow to almost $0.5 billion by 2030.
Clinical Trial Design
This was a randomized, observer-masked, phase 3 clinical trial to evaluate the safety and efficacy of Zerviate (cetirizine ophthalmic solution) 0.24% dosed twice daily compared to emedastine difumarate ophthalmic solution 0.05% dosed twice daily in Chinese patients with allergic conjunctivitis. The treatment period was 14 days, and the primary efficacy endpoint was a noninferiority analysis of the change from baseline in the itching score within the 24 hours prior to the Day 14 visit. A total of 296 patients were randomized across multiple clinical sites in China.
Zerviate Partnerships
Zerviate is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and most of the Southeast Asian markets. Nicox may potentially receive sales milestones of up to $17.2 million USD together with royalties of between 5% and 9% of net sales of Zerviate by Ocumension. Zerviate is commercialized in the U.S. by our exclusive U.S. partner Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical of Japan, and is also exclusively licensed to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets, and to Laboratorios Grin in Mexico.