Nicox Announces New Data from NCX 470 Mont Blanc Trial, Provides Development Updates

Nicox宣布NCX 470勃朗峰试验新数据，并提供开发进展更新。

March 04, 2025

2025年3月4日

Nicox, a global ophthalmology company, presented new data on its intraocular pressure (IOP)-lowering medication, NCX 470, at the 2025 American Glaucoma Society (AGS) Annual Meeting. The French company also provided updates on the NCX 470 Mont Blanc Phase 3 clinical trial, highlighting its superior performance over latanoprost, the current standard of care..

全球眼科公司Nicox在2025年美国青光眼学会（AGS）年会上展示了其降眼压（IOP）药物NCX 470的新数据。这家法国公司还提供了NCX 470勃朗峰三期临床试验的最新进展，强调了其优于目前标准治疗药物拉坦前列素的表现。

Key Findings from the NCX 470 Mont Blanc Trial

NCX 470勃朗峰试验的主要发现

NCX 470 operates through a dual mechanism of action, combining nitric oxide and a prostaglandin analog to effectively reduce IOP. The latest analysis revealed several advantages over latanoprost:

NCX 470 通过双重作用机制发挥作用，结合一氧化氮和前列腺素类似物有效降低眼压。最新分析显示，与拉坦前列素相比具有多个优势：

• A higher percentage of patients treated with NCX 470 achieved an IOP of ≤ 18 mmHg compared to those using latanoprost.

• 与使用拉坦前列素的患者相比，接受NCX 470治疗的患者中有更高比例的人达到了≤18毫米汞柱的眼内压。

• NCX 470 demonstrated a significantly greater average reduction in IOP.

• NCX 470 显示出显著更大的平均眼压降低。

• The medication's IOP-lowering effect remained consistent regardless of baseline IOP, whereas latanoprost's effectiveness depended on baseline IOP.

• 该药物的降眼压效果在不同基线眼压下保持一致，而拉坦前列素的效果则取决于基线眼压。

• A statistically significant higher proportion of patients receiving NCX 470 experienced an IOP reduction greater than 10 mmHg from baseline.

接受NCX 470治疗的患者中，眼压（IOP）从基线降低超过10毫米汞柱的比例在统计学上显著更高。

These findings, presented during the AGS meeting, reinforce the potential of NCX 470 as a differentiated treatment for glaucoma and ocular hypertension.

这些在AGS会议上发表的发现进一步证明了NCX 470作为青光眼和高眼压症的差异化治疗的潜力。

Development Updates and Future Plans

开发更新与未来计划

According to Doug Hubatsch, Chief Scientific Officer at Nicox, 'These data provide another example of where NCX 470 is differentiated from the standard-of-care for intraocular pressure reduction, latanoprost. We also look forward to announcing the results of the Whistler trial, investigating the mechanism of action of NCX 470, shortly, and the second pivotal Phase 3 trial, Denali, in Q3 of this year.'.

根据Nicox公司的首席科学官Doug Hubatsch的说法，“这些数据提供了另一个例子，证明了NCX 470与降低眼内压的标准疗法拉坦前列素有所不同。我们还期待着很快宣布研究NCX 470作用机制的Whistler试验结果，并在今年第三季度公布第二个关键的3期临床试验Denali的结果。”

The company confirmed that all developmental activities remain on schedule, with a U.S. New Drug Application (NDA) submission planned for the first half of 2026. The Whistler Phase 3b trial, which examines the dual mechanism of action of NCX 470, and the Denali Phase 3 trial, focused on patients with open-angle glaucoma or ocular hypertension, are expected to conclude by the end of 2025..

公司确认所有开发活动均按计划进行，预计于2026年上半年提交美国新药申请（NDA）。研究NCX 470双重作用机制的Whistler 3b期试验，以及针对开角型青光眼或高眼压症患者的Denali 3期试验，预计将在2025年底前完成。

Industry Impact

行业影响

If approved, NCX 470 could significantly improve treatment outcomes for patients with glaucoma and ocular hypertension. Its ability to provide consistent and superior IOP reduction compared to current therapies underscores its potential as a leading therapeutic option in the ophthalmology space.

如果获得批准，NCX 470 可显著改善青光眼和高眼压症患者的治疗效果。与现有疗法相比，其能够提供持续且更优的眼压降低效果，这凸显了其在眼科领域作为领先治疗选择的潜力。