Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has completed enrolment in its multicenter, dose escalating, U.S. Phase 2 clinical trial evaluating the safety and tolerability of NCX 4251 in acute exacerbations of blepharitis. The primary objective of this clinical trial is to select the dose(s) of NCX 4251 to advance into the next stage of development which will be a larger Phase 2b clinical trial. Nicox expects to report topline data in the fourth quarter of this year.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “As we continue to demonstrate our ability to execute on plan, we expect to report topline results for both the NCX 4251 and NCX 470 Phase 2 clinical trials in Q4 of this year. NCX 4251 is an innovative product candidate, both through the choice of active ingredient and form of application, which targets the unmet need in acute exacerbations of blepharitis. We estimate that the addressable market for this indication in the U.S. alone may be more than $700 million annually, rising to over $1 billion by 2024.”

As with NCX 470, we have worked with an excellent group of clinical investigators and their teams and we would like to thank them for their contributions to the timely execution of this trial. We look forward to reporting the results before the end of the year.” said Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox.

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals which Nicox believes is the first product candidate developed as a targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. Blepharitis is a common eye condition characterized by eyelid inflammation.