According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company’s application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired the Chinese rights to OC-01 and OC-02 simpinicline nasal spray for the treatment of dry eye disease from Oyster Point Pharma in August 2021. In the US, OC-01 was approved by the FDA in October 2021, and it is marketed as “Tyrvaya.”
Ji Xing Chief Medical Officer of Opthalmalogy Larry Li commented, “Over 200 million people in China are impacted by dry eye disease. A comfortable, convenient, long-lasting treatment stimulating natural tear film production has the potential to trigger a treatment paradigm-shift of dry eye disease. Receiving CTA approval to conduct the Phase 3 trial for OC-01 nasal spray demonstrates the demand for disruptive therapies in China and is one of the early steps in fulfilling our strong commitment to making innovative science available to Chinese patients with eye disease.”
Read the Ji Xing Pharmaceuticals press release.