NCX 470 is currently enrolling patients in two multi-regional Phase 3 glaucoma clinical trials, Mont Blanc and Denali. The objective of these two trials is to demonstrate statistically superior IOP lowering of once daily dosed NCX 470
Nicox announced that the results from the company’s Dolomites Phase 2 clinical trial of NCX 470 in patients with open-angle glaucoma or ocular hypertension was published online by the Journal of Glaucoma. NCX 470 is currently in two Phase 3 clinical trials.
Dolomites was a dose-response Phase 2 clinical trial comparing three concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension.
Aligned with previously reported topline results on Dolomites, NCX 470 0.065% achieved statistical superiority compared to latanoprost 0.005% at all time-matched points measured on day 28, with a peak improvement in intraocular pressure (IOP) lowering of 1.4 mmHg greater than latanoprost.
All tested concentrations of NCX 470 were statistically 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.
“As presented at the American Glaucoma Society in February 2020 by Dr. David Wirta, the Dolomites Phase 2 data demonstrate that NCX 470, a monotherapy with a dual mechanism of action, has the potential to be a new standard of care for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.” said Doug Hubatsch, Chief Scientific Officer of Nicox. “We are pleased to be able to share the results of this Phase 2 trial in a peer-reviewed publication with the international glaucoma community. We are looking forward to the results of the subsequent Phase 3 trials of NCX 470 – Mont Blanc and Denali – which use a higher dose of NCX 470, based on the results of an initial adaptive design dose-ranging phase of the Mont Blanc trial.”
NCX 470 is currently enrolling patients in two multi-regional Phase 3 glaucoma clinical trials, Mont Blanc and Denali. The objective of these two trials is to demonstrate statistically superior IOP lowering of once daily dosed NCX 470 ophthalmic solution 0.1% over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed prostaglandin analog in the U.S. for patients with open-angle glaucoma or ocular hypertension.
Read the publication “A Randomized, Controlled Comparison of NCX 470 (0.021%, 0.042% and 0.065%) and Latanoprost 0.005% in Patients with Open-Angle Glaucoma or Ocular Hypertension: The Dolomites Study” here.