Nicox releases results from Whistler phase 3b trial in IOP lowering eye drops

(Image Credit: AdobeStock/Anton Tolmachov)

Nicox has announced the results of its Whistler phase 3b exploratory clinical trial investigating the intraocular pressure (IOP)-lowering effects of NCX 470 ophthalmic solution, 0.1%, in healthy volunteers and ocular hypertensive patients.

NCX 470 is Nicox’s lead clinical product candidate and is a novel NO-donating bimatoprost eye drop with a dual mechanism of action (nitric oxide and prostaglandin analog).

The Whistler Phase 3b exploratory trial was a double-masked, placebo-controlled study in 18 healthy volunteers or patients with ocular hypertension. Measurements were taken at baseline and after 8 days at 1 PM and, for some parameters, at 3 PM. Patient population in the trial was primarily normotensive healthy volunteers with mean baseline IOPs of 16.6 mmHg and 16.9 mmHg for NCX 470 and placebo-treated patients, respectively.

Results showed that changes in aqueous humor flow rate trended towards significance when compared to placebo (p=0.072). Furthermore, outflow facility was positive at 1 PM (p=0.081) and significant at 3 PM (p=0.001), as was the diurnal outflow (p=0.004). The company noted in the results it believes this change is due to “the effect of nitric oxide on the trabecular meshwork.”

IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, according to the company, while episcleral venous pressure did not show a notable trend.

Doug Hubatsch, chief scientific officer of Nicox, commented on the results in a press release from the company.

“These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure,” said Hubatsch. “The therapeutic characteristics of NCX 470 demonstrated in the Phase 3 program so far show that we have an approvable and differentiated asset with a promising clinical profile.

The Whistler trial was an exploratory trial and is not a requirement for the submission of New Drug Applications for NCX 470, according to the company, and thus will not impact the development timeline.

A second Phase 3 clinical trial, named Denali, is currently ongoing, and results are expected from that in Q3 of 2025. The last American patient in Denali has completed their final visit, with Chinese patients having already completed theirs.

The company also noted it plans to submit a New Drug Application to the US Food and Drug Administration for NCX 470 and plans on using Mont Blanc and Denali to fulfill the regulatory requirements for safety and efficacy. The company did not specify a timeline for the NDA submission.

References:

1. Nicox announces results of the exploratory Whistler phase 3b glaucoma trial. Published May 14, 2025. Accessed May 15, 2025. https://www.nicox.com/wp-content/uploads/EN_WhistlerResultsMay2025_PR_FINAL.pdf