Core Insights - The company announced that its candidate drug OT-301 (NCX 470) has achieved non-inferiority compared to Latanoprost in its second Phase III clinical trial (Denali trial), meeting the efficacy requirements for new drug approval in China [1][2] - OT-301 demonstrated good safety and tolerability in the Denali trial, with significant statistical advantages in lowering intraocular pressure at three out of six time points compared to Latanoprost [1][2] Group 1 - The Denali trial is a three-month multi-regional Phase III clinical trial aimed at evaluating the safety and efficacy of OT-301 (0.1% concentration) compared to the standard therapy Latanoprost (0.005% concentration) for patients with open-angle glaucoma or ocular hypertension [2] - The trial included a long-term safety extension study, enrolling 696 patients across approximately 90 clinical sites in the US and China [2] - The first Phase III clinical trial (Mont Blanc trial) for NCX 470 was successfully completed in 2022, showing strong efficacy and safety [2] Group 2 - OT-301 (NCX 470) is a novel chemical entity invented by Nicox, designed to release nitric oxide, similar to a prostaglandin analog approved by the FDA for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension [2] - The company obtained exclusive rights from Nicox in December 2018 to develop, manufacture, and sell OT-301 in Greater China, later expanding these rights to South Korea and 12 Southeast Asian countries in March 2020 [2]
欧康维视生物-B(01477)：OT-301的第二项III期临床试验达到主要终点