OCUMENSION-B (01477.HK): NDA for OT-301 in Open-Angle Glaucoma or Ocular Hypertension Accepted by NMPA

NewTimeSpace News: On 11 September 2026, Ocumension Therapeutics (stock code: 01477) announced in a voluntary filing that the new drug application (NDA) for OT-301 (NCX 470, latanoprostene bunod) as a treatment to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA), supported by data from the Mont Blanc and Denali trials.

The first Phase III trial, Mont Blanc, was completed in the United States and China in 2022, with its primary endpoint demonstrating efficacy and safety. The second Phase III trial, Denali, is a multi-regional study evaluating the safety and efficacy of OT-301 ophthalmic solution (0.1%) versus latanoprost ophthalmic solution (0.005%) as the existing standard of care in lowering IOP, and in August 2025 met its primary endpoint of non-inferiority versus latanoprost, meeting China's efficacy requirements for the NDA.

OT-301 is a novel nitric oxide-donating prostaglandin analogue invented by Nicox S.A. and co-developed with the company, designed to release bimatoprost and nitric oxide to lower IOP. The company obtained an exclusive licence from Nicox in December 2018 to develop, manufacture, contract-manufacture, import, export and sell OT-301 in Greater China, and expanded the exclusive rights to South Korea and 12 Southeast Asian countries in March 2020.

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