Nicox SA’s exclusive U.S. licensee Kowa Pharmaceuticals America, Inc. announced that the FDA has accepted its new drug application (NDA) for K-911 (bimatoprost grenod)— better known as NCX 470.
This news follows just over a month after Kowa submitted its application package for the investigational glaucoma drop.
How about a quick recap on the therapeutic, then?
What it is: Nicox's lead asset — a novel nitric oxide (NO)-donating bimatoprost formulation combining two IOP-lowering components: NO and a prostaglandin analog (PGA).
A quick primer on each:
- Nitric oxide (NO): A naturally occurring signaling molecule that regulates IOP by activating soluble guanylate cyclase (sGC), a key enzyme in the NO pathway that governs blood pressure and vessel relaxation.
- Prostaglandin analogs (PGAs): A widely prescribed first-line class for lowering IOP in open-angle glaucoma (OAG) and ocular hypertension (OHT) — including several branded bimatoprost versions already on the market.
And how does it work?
The drop releases both bimatoprost and NO into the eye, lowering IOP through two separate pathways in OAG and OHT patients.
Why it stands out: Nicox reports that this dual mechanism has been clinically shown to outperform bimatoprost alone at lowering IOP.
Speaking of reporting—talk about its clinical data.
The two phase 3 trials included in K-911’s NDA: Mont Blanc and Denali.
Cumulative data (see here) from both studies was included in K-911’s (then-named NCX-470) NDA package.
Now circle back to the NDA.
The package was submitted at the end of July by Kowa as part of an exclusive U.S. licensing agreement (read up on that here) with Nicox.
And were there any special designations attached to it?
Like priority review? Nope, there was not.
What this means: The review period for K-911’s NDA leading up to the Prescription Drug User Fee Act (PDUFA) will follow the standard 10-month duration.
… which brings us to when?
The FDA has set the PDUFA target action date for April 30, 2027.
And if approved?
Pending a successful FDA review, the IOP-lowering eye drop could potentially launch to the U.S. commercial market by the second half (H2) of 2027.