The board of directors of Ocumension Therapeutics announced that the second phase III clinical trial of OT-301(NCX 470), namely the Denali trial, has been initiated in the United States by the group's licensing partner and the originator of NCX470, Nicox S.A. (‘Nicox’), with the first patients enrolled in the United States on November 9, 2020. OT-301(NCX 470), is a first-in-class, second-generation nitric oxide (NO)-donating bimatoprost analog under development by Nicox and the Group, which is intended to lower intraocular pressure (‘IOP’) in patients with open-angle glaucoma or ocular hypertension. The second phase III clinical trial of OT-301(NCX 470), namely the Denali trial, is a three-month phase III multi-regional clinical trial evaluating the safety and efficacy of OT-301(NCX 470) ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The Denali trial, which will also include a long-term safety extension, is expected to randomize approximately 670 patients, at approximately 50 clinical sites in the United States and the People's Republic of China (the ‘PRC’ or ‘China’). The Denali trial was designed to fulfil the regulatory requirements to support new drug application submissions of OT-301(NCX 470) in the United States and China. The collaboration between Nicox and the Group on the Denali trial has allowed the trial to be initiated earlier than planned and may potentially accelerate the new drug application submissions in both the United States and China. With the initiation of the Denali trial, the joint development of OT-301(NCX 470) is entering the final phase of development and remains on track. The first phase III clinical trial of OT-301(NCX 470), namely the ongoing Mont Blanc trial, was initiated in the United States in June 2020 and has been approved by the Center for Drug Evaluation of the National Medical Products Administration of the PRC in October 2020 to carry out part of the Mont Blanc trial in China. The top-line results of the Mont Blanc trial are currently expected in the fourth quarter of 2021.