• First publication of the data from the Mont Blanc Phase 3 trial in a peer-reviewed journal
• Authors conclude: "NCX 470 could become an important first-line therapy for IOP reduction in glaucoma."
• Topline results from second Phase 3 trial of NCX 470, Denali, expected in H2 2025
Nicox SA announced that the results from the Mont Blanc pivotal phase 3 trial comparing NCX 470 to latanoprost in the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension have been published in the peer-reviewed journal American Journal of Ophthalmology.
The principal author of the publication is Dr. Robert Fechtner, professor and chair of the Department of Ophthalmology at SUNY Upstate Medical University, Syracuse, NY and Chairman of Nicox’s U.S. Glaucoma Clinical Advisory Board. “We are pleased to see the publication of these data in such a recognized and respected journal,” said Doug Hubatsch, chief scientific officer of Nicox. “The data from the Mont Blanc phase 3 trial demonstrated the potential of NCX 470 and we look forward to seeing confirmation of this clinical profile in the upcoming results from the ongoing Denali phase 3 trial, expected in H2 2025. I’d also like to thank all the Mont Blanc study sites for their excellent work on this trial.”
The publication entitled “A Randomized, Controlled Comparison of NCX 470, a Nitric Oxide-Donating Bimatoprost, and Latanoprost in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The MONT BLANC Study” was published online in the American Journal of Ophthalmology on March 16, 2024 and is available by clicking here.
The Mont Blanc publication concludes that “The NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with open-angle glaucoma or ocular hypertension at all 6 time points. With a dual mechanism of action that enhances both uveoscleral and trabecular outflow, NCX 470 could become an important first-line therapy for IOP reduction in glaucoma.”
About NCX 470
NCX 470, Nicox’s lead clinical asset, is a novel nitric oxide-donating bimatoprost eye drop.
The Denali phase 3 clinical trial evaluating NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, being conducted in the U.S. and China, is on track to generate topline results in H2 2025. 80% of the target number of patients have been randomized in the trial and completion of recruitment of U.S. patients is expected in Q4 2024.
Supportive development data required for the preparation of the U.S. New Drug Application (NDA) is expected to be available on or before the completion of the Denali trial.
The database from the trial will not be locked until after the last patient has completed their final trial visit in China, which drives the timing of the Denali results.