Nicox Highlights Successful 2020 Development Progress and Clinical Milestones for 2021

• Initiated two Phase 3 trials with NCX 470 in glaucoma and a Phase 2b trial with NCX 4251 in blepharitis in 2020
• Partner Ocumension Therapeutics initiated a Phase 3 trial in China with ZERVIATE™ in allergic conjunctivitis in December 2020
• Top-line results for NCX 470 Mont Blanc Phase 3 trial and NCX 4251 Mississippi Phase 2b trial both currently due in Q4 2021

January 5, 2021 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today highlighted the strong progress in its development programs in 2020 and the key clinical milestones expected in 2021.

 

Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated “We have positioned ourselves as a major player among international ophthalmic R&D companies.  We achieved outstanding progress in 2020 with the start of four large clinical trials, covering our three major assets, despite the challenging environment caused by the COVID-19 pandemic.  Looking ahead, we expect significant milestones in 2021, above all the results from late-stage clinical trials with our lead assets NCX 470 and NCX 4251.  Furthermore, thanks to our unique advantage of having licensing revenue from two products commercialized in the U.S., and partnered in other markets, we anticipate steadily increasing revenue for many years to come to support our growth.”

Overview of Our Late-Stage Clinical Pipeline

      ·NCX 470, Nicox’s lead clinical product candidate, a novel nitric oxide (NO)-donating prostaglandin analog, is being evaluated in the Mont Blanc and Denali Phase 3 clinical trials for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  Top-line results are currently expected in Q4 2021 for Mont Blanc and in Q4 2022 for Denali.  Together Mont Blanc and Denali trials will support New Drug Application (NDA) submissions in the U.S. and China.

• NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is being evaluated in the Mississippi Phase 2b clinical trial for the treatment of acute exacerbations of blepharitis.  Top-line results are currently expected in Q4 2021.  If successful in meeting the primary efficacy endpoint previously agreed with the U.S. Food and Drug Administration (FDA), the Mississippi trial could represent the first of two pivotal trials needed to support the submission of an NDA for the treatment of blepharitis in the U.S.  
• ZERVIATE^™, (cetirizine ophthalmic solution), 0.24%, the first and only topical ophthalmic formulation of the antihistamine cetirizine, is being evaluated in a confirmatory Phase 3 clinical trial in China by our partner Ocumension, to support a Chinese New Drug Application.  ZERVIATE is already commercialized in the U.S. by our partner Eyevance Pharmaceuticals, which was acquired by Santen Pharmaceutical Co., Ltd of Japan in September 2020 for $225 million.

We continue to closely watch the spread and impact of the COVID-19 pandemic.  We do not currently anticipate delays in our clinical timelines but we are monitoring the situation and will provide an update when needed.