Chinese ophthalmology specialist Ocumen Therapeutics (HKG: 1477) has announced the enrollment of more than 140 patients in the second Phase III Denali study for its OT-301 (NCX470) in China. This follows the commencement of the first Phase III MontBlanc study for the drug in the United States in June 2020, which demonstrated strong efficacy and safety in first-line treatment.
OT-301 (NCX 470): A Novel NO Donor Bimatoprost Analog
OT-301 (NCX 470) is a first-in-class second-generation nitric oxide (NO) donor bimatoprost analog. It was in-licensed from France-based Nicox SA in a EUR 36.25 million deal for Greater China rights in December 2018. The deal was expanded to South Korea and 12 other countries in Southeast Asia in March 2020. The three-month study is designed to assess the efficacy and safety of OT-301 (0.1% concentration) compared with the current standard treatment latanoprost (0.005% concentration) in reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Study Design and Objectives
The Phase III Denali study aims to provide a comprehensive evaluation of OT-301’s performance against the existing standard of care. By comparing the efficacy and safety of OT-301 with latanoprost, the study will contribute to the understanding of its potential as a new treatment option for patients with glaucoma or ocular hypertension.-Fineline Info & Tech
