Nicox Reveals Whistler Phase 3b Glaucoma Trial Findings

Nicox SA, an international company specializing in ophthalmology, has unveiled findings from its Whistler Phase 3b exploratory clinical trial, focusing on the dual mechanism of action of NCX 470. This trial is part of their ongoing efforts to develop treatments for lowering intraocular pressure (IOP) in patients with ocular hypertension and open-angle glaucoma.

The trial, which took place in France, aimed to investigate how NCX 470, a novel eye drop formulation, impacts various parameters in the aqueous humor, particularly through its dual mechanism involving nitric oxide and prostaglandin analogs. The study involved 18 participants, both healthy individuals and those with ocular hypertension, to evaluate changes in IOP and other aqueous humor dynamics.

Key findings from the Whistler trial indicated that several parameters influenced by nitric oxide, such as trabecular meshwork aqueous humor dynamics, showed statistically significant changes or trends favoring NCX 470. On the other hand, parameters that respond to prostaglandin analogs also showed positive trends. However, changes in episcleral venous pressure did not demonstrate a notable trend compared to the placebo.

The Whistler trial was structured as a double-masked, placebo-controlled study, with measurements taken at different time intervals. Results showed that changes in the aqueous humor flow rate approached significance when compared to the placebo, while the outflow facility demonstrated positive trends at the 1 pm time point and significant results at the 3 pm time point. Additionally, diurnal outflow was significantly positive, reinforcing the dual mechanism effect of NCX 470 through both nitric oxide-stimulated pathways and prostaglandin-stimulated pathways.

Safety data from the Whistler trial mirrored the results from the Mont Blanc Phase 3 trial, indicating a consistent safety profile for NCX 470. The trial was primarily exploratory and not a necessity for New Drug Application submissions, ensuring that the development timeline remains unaffected.

Doug Hubatsch, Chief Scientific Officer of Nicox, expressed optimism about the results, emphasizing the potential of NCX 470 as an approvable and differentiated asset with a promising clinical profile. The outcomes suggest further investigation into the dual mechanism effect of NCX 470 on IOP might be warranted.

The Whistler study primarily involved normotensive healthy volunteers, marking a different patient profile compared to the Phase 3 glaucoma program. Despite this difference, the safety and efficacy of NCX 470 have already been established in the Mont Blanc trial, the first of two Phase 3 trials. The results from Mont Blanc have been extensively published, and another Phase 3 trial, Denali, is currently ongoing.

NCX 470 is anticipated to fulfill regulatory requirements for safety and efficacy to support New Drug Application submissions in the United States and China, with exclusive licensing agreements for marketing in these regions. The eye drop is also licensed to Kowa for the Japanese market.

Nicox SA continues to advance its pipeline in ophthalmology with innovative solutions designed to maintain vision and improve ocular health. The company is also developing other products, such as NCX 1728, and has existing commercial products like VYZULTA® and ZERVIATE® available in multiple global markets.

Through its ongoing research and trials, Nicox SA aims to provide effective treatments for eye health, leveraging their expertise in nitric oxide-donating compounds to explore new therapeutic possibilities.