The board (the "Board") of directors of the Company announced that the phase III clinical trial of OT-1001 (ZERVIATE), a potent and highly selective histamine-1 receptor antagonist with anti-allergic properties, has achieved its primary clinical endpoint and received positive results. OT-1001 (ZERVIATE) was developed by Nicox Ophthalmics Inc. ("Nicox"). OT-1001 is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the United States for ocular itching associated with allergic conjunctivitis.

Studies have shown that OT-1001 is a safe and effective antihistamine therapeutic agent. OT-1001 has a rapid onset of action, and the effect is able to last for at least 8 hours after administration. OT-1001 covers a wide range of patients.

In addition to treating adult patients, the safety and effectiveness of OT-1001 has been established in pediatric patients two years of age and older, therefore meeting the current clinical needs of treating pediatric patients with allergic conjunctivitis. The Group obtained an exclusive license from Nicox to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell (or otherwise commercialize) OT-1001 (ZERVIATE) in the Greater China region in March 2019, and extended the exclusive rights to 11 countries in Southeast Asia in March 2020. In December 2020, the first patient has been successfully enrolled and dosed in the phase III clinical trial of OT-1001 in China.

The phase III clinical trial of OT-1001 was designed as a randomized, observer-masked, positive control, multi-center parallel clinical trial to evaluate the safety and efficacy of the cetirizine hydrochloride ophthalmic solution of 0.24% concentration in comparison with emedastine difumarate ophthalmic solution of 0.05% concentration for Chinese patients with allergic conjunctivitis. A total of 296 patients were randomized across multiple clinical sites in China. O -1001 was found to be non-inferior 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.

OT-1001 was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate. The successful completion of this clinical trial is an important step towards commercialization of OT-1001.