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The NMPA has accepted NDA for OT-301(bimatoprost grenod; NCX 470) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The NDA was backed by the P-III (Mont Blanc & Denali) trial data, where Mont Blanc’s 1EP showed robust efficacy & safety, plus Denali met its 1EP of non-inferiority of OT-301 as compared to latanoprost in Aug 2025
The Group obtained exclusive rights from Nicox to develop, make, have made, import, export & sell OT-301 in Greater China in Dec 2018, later expanding the license to Korea & 12 Southeast Asian countries in Mar 2020
Ref: Ocumension | Image: Ocumension | Press Release
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The post Ocumension Therapeutics Reports NMPA NDA Acceptance of OT-301 to Lower Intraocular Pressure appeared first on PharmaShots.
Ocumension Therapeutics Reports NMPA NDA Acceptance of OT-301 to Lower Intraocular Pressure | PharmaVoice