OCUMENSION-B (01477) announced that OT-301 (NCX 470), one of the group's primary drug candidates co-developed with Nicox S.A. (Nicox) as a first-in-class nitric oxide (NO) donating bimatoprost analog, has achieved its primary endpoint of non-inferiority compared to latanoprost in its second Phase III clinical trial (Denali trial), meeting the efficacy requirements for new drug approval in China.

OT-301 demonstrated favorable safety profile with good patient tolerance in the Denali trial. Additionally, in pre-specified secondary efficacy analyses, OT-301 showed statistically significant superiority over latanoprost in reducing baseline intraocular pressure, with p-values less than 0.05 at three of six time points.

The Denali trial is a three-month Phase III multi-regional clinical study designed to evaluate the safety and efficacy of OT-301 (NCX 470) ophthalmic solution (0.1% concentration) compared to the current standard therapy latanoprost ophthalmic solution (0.005% concentration) in reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The Denali trial includes a long-term safety extension study and has completed enrollment of 696 patients across approximately 90 clinical sites in the United States and China.

NCX 470's first Phase III clinical trial (Mont Blanc trial) was successfully completed by Nicox in the United States and China in 2022, with primary results demonstrating robust efficacy and safety.

OT-301 (NCX 470) is a novel chemical drug invented by Nicox, designed to release bimatoprost (a U.S. Food and Drug Administration-approved prostaglandin analog) and nitric oxide for reducing intraocular pressure in patients with open-angle glaucoma and ocular hypertension.

The group obtained an exclusive license from Nicox in December 2018 to develop, manufacture, contract manufacture, import, export, and commercialize OT-301 (NCX 470) in Greater China, and expanded the exclusive rights to Korea and 12 Southeast Asian countries in March 2020.