The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma
Shots:
- The FDA has accepted NDA for NCX 470 (bimatoprost grenod) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (PDUFA: Apr 30, 2027)
- The NDA, submitted by US licensee Kowa, is supported by P-III (Mont Blanc & Denali) trial data showing IOP reductions of up to 10mmHg with a favorable safety profile. An approval milestone will be payable to Nicox, followed by royalties on sales
- NCX 470 NDA is also filed in China, with US commercialization to start from H2’27, subject to approvals. A P-III program is also ongoing in Japan to support potential approval in the country
Ref: Globenewswire | Image: Nicox | Press Release
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