Nicox’s NCX 470 Demonstrates Significant Intraocular Pressure Lowering in Dolomites Phase 2 Glaucoma Trial
July 1, 2021
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Results Demonstrating Superior Efficacy to Current Standard of Care Presented at World Glaucoma E-Congress 2021
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Phase 3 on track with first trial results expected in Q2 2022
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, presented results from the Dolomites Phase 2 clinical trial showing that NCX 470, a novel nitric oxide (NO)-donating prostaglandin analog (PGA), produced significantly greater intraocular pressure (IOP) lowering effects in glaucoma patients compared with the current standard of care, latanoprost.
In Dolomites, a dose-response Phase 2 clinical trial evaluating three concentrations of NCX 470 compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension, NCX 470 0.065% achieved superiority compared to latanoprost 0.005% at all time points on day 28 with up to 1.4 mmHg superior IOP lowering. All tested concentrations of NCX 470 were non-inferior to latanoprost and the dose response of NCX 470 showed improved IOP lowering with each incremental concentration. NCX 470 was safe and well-tolerated with no drug-related serious adverse events and no evidence of treatment-related systemic side effects. The presentation of the results by Dr. David Wirta, one of the clinical investigators in the trial, is available during the World Glaucoma Congress 2021 (June 30 to July 3 2021). The Dolomites trial was completed in late 2019 and the results are detailed here.
“The Phase 2 Dolomites trial demonstrated that NCX 470 has the potential to be a new standard of care for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. These impressive data showed superior efficacy against latanoprost, the most prescribed prostaglandin analog for patients with open-angle glaucoma or ocular hypertension, and importantly, also suggested that greater efficacy may be possible at concentrations higher than those used in this dose-ranging trial,” said Dr. Wirta, Medical Director, Eye Research Foundation, Newport Beach, CA, USA and one of the clinical investigators in the Dolomites trial, “NCX 470 was well-tolerated, and the highest dose used in the trial suggests that a higher dose (0.1%) currently being evaluated in Phase 3 has the potential for greater IOP lowering without significant additional risk.”
NCX 470 is currently in two multi-regional Phase 3 glaucoma clinical trials, Mont Blanc and Denali. The objective with these two trials is to demonstrate statistically superior efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed PGA in the U.S., for the lowering of IOP. Results from the first Phase 3 trial, Mont Blanc, are currently expected in Q2 2022. Results from the second Phase 3 trial, Denali, are now expected in 2023, previously announced as Q4 2022.