OCUMENSION-B (01477) has announced that its New Drug Application (NDA) for OT-301 (NCX 470, Gebe前列素) has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration. The application is for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, and is supported by data from the Mont Blanc and Denali trials.

The first Phase III clinical trial for OT-301 (NCX 470, Gebe前列素), designated as the Mont Blanc study, was successfully completed in both the United States and China in 2022. The primary endpoints demonstrated significant efficacy and a favorable safety profile. The second Phase III trial, known as Denali, is a multi-regional study designed to evaluate the safety and efficacy of OT-301 eye drops (0.1% concentration) compared to the current standard of care, latanoprost eye drops (0.005% concentration), for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

In August 2025, the Denali trial achieved its primary endpoint of non-inferiority compared to latanoprost, satisfying the efficacy requirements for NDA submission in China. OT-301 (NCX 470, Gebe前列素) is one of the group's key drug candidates, representing a novel nitric oxide (NO) donating prostaglandin analog co-developed with Nicox S.A. (Nicox). This new chemical entity, invented by Nicox, is designed to release bimatoprost, a prostaglandin analog already approved by the U.S. Food and Drug Administration, along with nitric oxide to reduce IOP in patients suffering from 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 sell OT-301 (NCX 470, Gebe前列素) in Greater China. In March 2020, this exclusive right was expanded to include South Korea and twelve Southeast Asian countries.