Nicox’s NCX 470 Dolomites Phase 2 results published in Journal of Glaucoma

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.