Hong Kong, China, September 11, 2026
Ocumension Therapeutics has announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for OT-301 (NCX 470, bimatoprost grenod), an investigational ophthalmic solution being developed to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The NDA has been accepted by the Center for Drug Evaluation of the NMPA and is supported by results from the Mont Blanc and Denali Phase III clinical trials. The regulatory milestone moves OT-301 into the Chinese NDA review process and represents an important step toward potential commercialization of the ophthalmic therapy in China.
Ocumension Advances OT-301 Toward China Approval
The acceptance of the OT-301 NDA follows the completion of two key Phase III studies evaluating the safety and efficacy of the investigational treatment. The first Phase III study, known as the Mont Blanc trial, was completed in the United States and China in 2022. According to Ocumension, the trial demonstrated robust results for its primary endpoint, supporting continued development of the candidate for patients with elevated IOP. The second pivotal study, the Denali trial, was designed as a multi-regional Phase III clinical trial comparing OT-301 ophthalmic solution, 0.1%, with latanoprost ophthalmic solution, 0.005%, a current standard treatment for lowering IOP. The study evaluated whether OT-301 could provide comparable efficacy and safety in patients with open-angle glaucoma or ocular hypertension. In August 2025, the Denali trial achieved its primary endpoint of non-inferiority compared with latanoprost, meeting the efficacy requirements needed to support an NDA submission in China. The acceptance of the application by the NMPA now allows the Chinese regulatory review process to proceed.
OT-301 Uses Dual-Action Mechanism
OT-301 (NCX 470, bimatoprost grenod) is described as a novel nitric oxide (NO)-donating prostaglandin analog being jointly developed by Ocumension Therapeutics and Nicox S.A. The compound is a new chemical entity designed to release both bimatoprost and nitric oxide following administration. Bimatoprost is an established prostaglandin analog used to reduce IOP, while nitric oxide has a complementary role in regulating aqueous humor outflow and lowering pressure inside the eye. By combining the effects of a prostaglandin analog with NO donation in a single molecule, OT-301 is designed to provide a differentiated pharmacological approach to managing elevated intraocular pressure. Elevated IOP is a major risk factor associated with glaucoma, a group of eye diseases that can progressively damage the optic nerve and lead to irreversible vision loss. Lowering IOP remains an important component of glaucoma management, making the development of new ophthalmic therapies clinically relevant for patients who require long-term pressure control. The Phase III program provides the primary clinical evidence supporting the Chinese NDA. However, NMPA acceptance does not represent final marketing approval, and the regulatory review will determine whether OT-301 meets the requirements for commercialization in China.
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Ocumension Expands Regional Rights for OT-301
Ocumension has held an exclusive license from Nicox since December 2018 to develop, manufacture, have manufactured, import, export and sell OT-301 in Greater China. The company’s rights were subsequently expanded in March 2020 to include Korea and 12 countries in Southeast Asia. The NDA acceptance therefore represents an important regulatory milestone within a broader regional development and commercialization strategy. If approved, OT-301 could provide Ocumension with an additional treatment option for patients with open-angle glaucoma and ocular hypertension across its licensed territories. The regulatory progress also highlights the company’s continued focus on ophthalmic drug development, particularly therapies addressing diseases associated with vision loss and elevated IOP. The company cautioned that it cannot guarantee the successful commercialization of OT-301, and further regulatory review will be required before the therapy can potentially reach the Chinese market. The acceptance of the OT-301 NDA by China’s NMPA marks a significant transition from clinical development to regulatory evaluation. Results from the Mont Blanc and Denali trials will form the foundation of the review as Chinese regulators assess the candidate’s efficacy, safety and overall benefit-risk profile.
Source: Ocumension Therapeutics press release
