New data sheds light on how Nicox’s eye drop may improve outflow and reduce pressure—twice over.
Nicox (Sophia Antipolis, France) has released new findings from its Whistler Phase IIIb exploratory clinical trial, offering insight into how its lead drug candidate, NCX 470, may reduce intraocular pressure (IOP) through two biological pathways.
Nicox makes the announcement on its LinkedIn page.
The randomized, double-masked, placebo-controlled study included 18 participants, both healthy volunteers and patients with ocular hypertension. Subjects were treated with NCX 470 ophthalmic solution (0.1%) for eight days. Researchers measured several aqueous humor dynamics before and after treatment, with post-treatment readings taken at 1pm and 3pm.
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Several parameters showed promising trends. Aqueous humor flow rate neared statistical significance compared to placebo (p = 0.072), and outflow facility reached statistical significance at 3pm (p = 0.001), with a positive trend earlier at 1pm (p = 0.081). Diurnal outflow was also significant (p = 0.004). Uveoscleral outflow and IOP-lowering effects were statistically significant at all measured timepoints. However, episcleral venous pressure did not show any notable changes.
“We believe that the outcomes in favor of NCX 470 in several trabecular meshwork aqueous humour dynamics parameters are due to nitric oxide. These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure,” said Doug Hubatsch, chief scientific officer at Nicox, in a news release.
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The findings support NCX 470’s dual mechanism of action for IOP lowering through both the conventional (nitric oxide-stimulated) and the uveoscleral (prostaglandin-stimulated) pathways. The safety profile seen in the Whistler trial was consistent with findings from Mont Blanc, the company’s first Phase III study.
Prof. Philippe Denis explains NCX 470’s potential.
Importantly, the Whistler trial was exploratory and is not required for New Drug Application (NDA) submissions for NCX 470. The patient population primarily consisted of normotensive healthy volunteers with mean baseline IOP of 16.6 mmHg for NCX 470 patients and 16.9 mmHg for placebo treated patients, which differs from the patient profile in the Phase III glaucoma program.
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“The therapeutic characteristics of NCX 470 demonstrated in the Phase III program so far shows that we have an approvable and differentiated asset with a promising clinical profile,” Mr. Hubatsch added. “We look forward to announcing the safety and efficacy results from our ongoing Phase III trial, Denali, expected in the third quarter of this year.”
NCX 470 is Nicox’s lead clinical product candidate, a novel NO-donating bimatoprost eye drop currently in Phase III clinical development. Both the Mont Blanc and Denali trials have been designed to fulfill regulatory requirements for safety and efficacy to support NDA submissions in both the United States and China.
