Nicox SA is on a positive trajectory toward an eventual new drug application (NDA) submission following the FDA’s promising feedback for its investigational glaucoma eye drop.
Let’s start with this drop.
We last reported on NCX 470 in September 2026 after Nicox shared positive phase 3 clinical data.
But before we discuss that, a little rundown on it is in order:
What it is: A novel nitric oxide (NO)-donating bimatoprost formulation of intraocular pressure (IOP)-lowering components (of NO) and prostaglandin analogs (PGAs).
Its mechanism of action (MOA): Is two-fold, with the drop releasing both bimatoprost and NO into the eye to not only reduce IOP but achieve a superior IOP-lowering effect than would be possible if using bimatoprost alone.
- Its target conditions: Glaucoma and ocular hypertension (OHT).
What’s the latest on its clinical performance?
See here for details on NCX 470’s phase 3 clinical program, which encompassed three studies (though only data from two trials will be included in that future NDA package).
As for the most recent data readout: That would be the aforementioned September 2026 reporting, which was from the second of those two trials that’ll be in the NDA: Denali (NCT04630808).
- The gist of that topline data: 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.
Now to this pre-NDA meeting.
First: The meeting was conducted in partnership with Kowa Company, Ltd.
- Why Kowa: The Japanese pharma company will receive the exclusive rights to develop and commercialize NCX 470 in the United States (as well as all global markets except in China, South Korea and Southeast Asia).
And just how positive was the FDA’s feedback?
Nicox shared a few key updates:
- The meeting confirmed its current data package, as well as the proposed content and format of the NDA, is “generally accepted for submission”
- The FDA requested complementary pharmacokinetic data—which will be "generated in a small number of patients as part of an ongoing study in Japan” and not impact any timelines
Did we get a timeframe for this NDA?
We did … the NDA remains on track for a summer 2026 submission.
- The timeframe: Sometime between June and September.
Nicox’s Executive Vice President and Chief Scientific Officer Doug Hupatsch noted that the company will begin transferring ownership of the NDA to Kowa, who will submit the application .
Noted. Any other dates to keep in mind?
For NCX 470’s U.S. regulatory pathway? Nope. But we did also get an update on a few other key milestones for its global regulatory advancement …