Nicox Provides First Quarter 2021 Business Update and Financial Highlights - Seite 2

Innovative pipeline

• 50% of patients in the NCX 470 Mont Blanc Phase 3 glaucoma clinical trial have now been randomized with top-line results currently on track to be announced during Q2 2022.
• Ocumension Therapeutics, Nicox’s partner for NCX 470 in China and Southeast Asia, received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct the Chinese part of the ongoing NCX 470 Denali Phase 3 trial for the lowering of IOP in patients with open angle glaucoma or ocular hypertension. Ocumension is also currently evaluating ZERVIATE in a confirmatory Phase 3 clinical trial in China, which was initiated in December 2020 to support a New Drug Application there for the treatment of ocular itching associated with allergic conjunctivitis.
• Pre-clinical IOP-lowering results on a new class of non-prostaglandin analog, NO-donating compounds, were published in the Journal of Ocular Pharmacology and Therapeutics, a leading scientific journal. Elevated IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 inhibition within the same molecule.   NCX 1728 is the first in this new class of compounds to be selected for development.

Commercial products

• VYZULTA has been approved in Brazil, the largest market in Latin America. VYZULTA is commercialized by Nicox’s exclusive worldwide partner Bausch + Lomb in the U.S. (2017), Canada (2019), Argentina (2020), Mexico (2020) and Hong Kong (2020), and is now approved in 5 other territories – Brazil, Colombia, South Korea, Taiwan and Ukraine.
• The number of prescriptions¹ for VYZULTA in the U.S. increased by 10.6% in the first quarter of 2021 compared to the first quarter of 2020.
• ZERVIATE U.S. prescriptions² increased by 29.1% in the first quarter of 2021 over the fourth quarter of 2020. ZERVIATE has been commercialized in the U.S. since March 2020 by Nicox’s U.S. partner Eyevance Pharmaceuticals. Eyevance has entered into a partnership with Hikma Pharmaceuticals for the co-promotion of ZERVIATE in the U.S. who will be responsible for promoting ZERVIATE to U.S. healthcare professionals working outside the eyecare specialty, with all sales continuing to be booked by Eyevance, and on which Nicox will receive royalties.

Corporate