Nicox SA announced that its exclusive U.S. licensee Kowa Company, Ltd. has submitted a new drug application (NDA) for NCX 470, an investigational glaucoma drop.
This latest update follows a positive pre-NDA meeting with the FDA earlier this year.
Big news! Let’s get a refresh on NCX 470.
What it is: As Nicox’s lead asset, this is a novel nitric oxide (NO)-donating bimatoprost formulation that pairs two intraocular pressure (IOP)-lowering components—NO and a prostaglandin analog (PGA).
Here's a quick primer on each:
- Nitric oxide (NO): A small, naturally occurring signaling molecule that plays a key role in IOP regulation by activating soluble guanylate cyclase (sGC).
- On sGC: As a key enzyme in the NO signaling pathway, it helps regulate blood pressure and blood vessel relaxation.
- Prostaglandin analogs (PGAs): Already widely prescribed, this drug class is considered a convenient, effective first-line option for lowering IOP in open-angle glaucoma (OAG) and ocular hypertension (OHT) patients.
- Several branded versions of bimatoprost are already on the market.
Next up: its mechanism of action.
The drop is formulated to release both bimatoprost and NO into the eye, lowering IOP via two separate pathways in OAG and OHT patients.
Why it stands out: The NO-bimatoprost pairing delivers a dual mechanism of action (MOA) that, according to Nicox, has been clinically shown to achieve superior IOP-lowering compared to bimatoprost alone.
Moving on to this NDA … what do we know?
As mentioned, the package was submitted by Kowa, a Japanese pharmaceuticals company.
In case you missed it: Nicox and Kowa kicked off an agreement last summer in which Kowa will receive the exclusive rights to develop and commercialize NCX 470 in the United States and all other global territories (excluding a select few).
- As part of this partnership:
- Kowa will cover all regulatory and commercialization costs
- Nicox may receive regulatory and sales milestones as well as royalties on worldwide sales.
- In fact, the company will receive its first milestone payment following the NDA submission
Also, check out Nicox’s global partnering strategy for NCX 470.
Noted. So what data was included in the package submission?
That would be positive findings from two phase 3 clinical trials:
- Mont Blanc (NCT04445519)
- Denali (NCT04630808)
To note: The cumulative data from these studies will also support a future submission for regulatory approval in China.
Give me the highlights of NCX 470’S performance in these studies.
Across both trials, NCX 470 achieved clinically meaningful reductions in IOP, along with a favorable safety profile.
Looking at the Mont Blanc study:
- The study achieved its primary objective in demonstrating noninferiority to latanoprost, with NCX 470 exhibiting an IOP lowering of 8.0 to 9.7 mmHg from baseline
- See here for more on its positive topline data
- And check out these updated findings from March 2025 (which essentially determined the eye drop met the efficacy standard for FDA approval in the U.S.).
And in the Denali study:
- The study met its primary objective of non-inferiority in lowering IOP from baseline compared to latanoprost (7.9 to 10.0 mmHg vs 7.1 to 9.8 mmHg, respectively)
- See here for a breakdown of that lowering effect.
Nice! Now let’s talk timeline.
In sharing the NDA submission news, Kowa noted that NCX 470 is expected to undergo the FDA’s standard 12-month review period.
With that in mind: Pending the federal agency finds no issue with its NDA, the IOP-lowering drop could receive approval by mid-2027.
And if that’s the case: We may be looking at a potential commercial launch before the end of 2027.