Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Summary

The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.

Timeline

Start

2020-06-01

Primary completion

2022-09-16

Completion

2022-09-16

Outcome

Met primary endpoint

release “NCX 470 met the primary efficacy endpoint of non -inferiority to latanoprost at all 9 of 9 ti mepoints measured in the Mont Blanc trial.” nicox.com ↗

release “Achieving the primary endpoint in both Denali and the first NCX 470 Phase 3 trial, Mont Blanc” nicox.com ↗

Publications

• Mansberger SL, Fechtner R, Lopez K, Hubatsch D. A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study. Contemp Clin Trials. 2024 Dec;147:107730. doi: 10.1016/j.cct.2024.107730. Epub 2024 Oct 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Latanoprost	Small molecule	0.005 %	Topical
Subject	NCX 470	Unknown	0.065 %	Topical
Subject	NCX 470	Unknown	0.1 %	Topical

Indications