• NCX 470 0.065% produced significantly superior intraocular pressure (IOP) lowering compared with latanoprost 0.005% in secondary analyses

  • NCX 470 showed improved IOP lowering with each incremental concentration of NCX 470 tested, setting the stage for potentially further IOP lowering at a higher dose

  • Phase 3 clinical program expected to be initiated in Q2 2020 with 0.065% and 0.1% doses, pending End-of-Phase 2 meeting with U.S. Food and Drug administration (FDA)

  • Independent market research suggests NCX 470 with the present product profile could capture at least 25% of existing branded U.S. first-line therapy market, and a larger share with higher IOP reduction

Sophia Antipolis, France

Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the results of secondary analyses of its Dolomites Phase 2 trial with NCX 470 for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Positive top-line results were reported on October 2. 2019.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “The secondary analyses we report today provide further strong support to the compelling clinical potential of NCX 470 in the treatment of ocular hypertension and glaucoma. Furthermore, the primary market research we have conducted in the U.S. via an independent agency already indicates the clear commercial opportunity of NCX 470.”

Tomas Navratil, Ph.D., EVP and Head of Development, stated,As the next step, in our End-of-Phase 2 meeting with the U.S. FDA early next year, we intend to propose conducting our Phase 3 trials with 0.065%, the highest concentration used in the Dolomites trial, and a 0.1% concentration. This higher concentration has the potential for additional incremental improvement in IOP lowering, thus further enhancing the clinical and commercial profile of NCX 470.”

In the Dolomites trial, NCX 470 met the primary endpoint of non-inferiority and also demonstrated statistical superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions, in multiple pre-specified analyses, with a 7.6 to 9.8 mmHg IOP reduction from baseline.

Key Points from Additional Analysis of Dolomites Trial

  • All doses of NCX 470 (0.021%, 0.042%, and 0.065%) met pre-specified primary efficacy endpoint of non-inferiority to latanoprost for reduction from baseline in mean diurnal IOP at Day 28.
  • Dose dependent IOP reduction from baseline in mean diurnal IOP at Day 28 showed improved IOP lowering with each incremental concentration of NCX 470 tested, thus creating the potential for additional IOP lowering with a higher concentration of NCX 470 which, subject to FDA agreement, we intend to test in Phase 3 clinical trials.
  • In a responder analysis, 37% of patients demonstrated an IOP reduction of ≥ 2 mmHg vs. the mean IOP reduction with latanoprost, and 27% of patients for ≥ 3 mmHg.
  • NCX 470 was well tolerated. The most frequently reported adverse event was conjunctival hyperemia in 16.8% of the NCX 470 (0.065%) patients vs. 6.5% of latanoprost patients; most of these events were rated as mild. There were no drug-related serious adverse events and no evidence of treatment-related systemic effects.

For the comprehensive results, please see the Appendix to this Press Release.

Market Research

  • Independent market research on multiple potential profiles for NCX 470 was carried out with 40 interviews with U.S. ophthalmology key opinion leaders, high volume prescribers including ophthalmologists and optometrists, and third-party payers.
  • Profiles varied by increasing superiority of IOP reduction compared to latanoprost.
  • There is an opportunity for an impactful product with any of the three profiles tested and the market potential increased with the magnitude of IOP reduction. The profile closest to that of NCX 470 (0.065%) observed in the Phase 2 trial had the potential to capture at least 25% of existing branded U.S. first-line therapy glaucoma market by value.

For the comprehensive details of the Market Research, please see the Appendix to this Press Release