OCUMENSION-B (01477): Topline Results of the Primary Analysis at Month 36 of the Global Multicenter Phase III Clinical Trial of OT-101 (0.01% Atropine Sulfate Eye Drops)

OCUMENSION-B (01477) announces that OT-101 (0.01% Atropine Sulfate Eye Drops) is a low-concentration (0.01%) atropine eye drop independently developed by the Group for slowing or reducing the progression of myopia in children and adolescents. However, the instability of low-concentration atropine solutions has long been a technical barrier to commercialization. OT-101 uses an exclusively designed innovative sealed split device, which resolves the stability issue of low-concentration atropine solutions in a neutral environment. The suitable pH value also improves patient comfort during administration and enhances medication compliance. The board of directors of the Company hereby announces that the Group has recently been informed of the topline results of the primary analysis at Month 36 of the global multicenter Phase III clinical trial (the Phase III Clinical Trial) of OT-101. The Phase III Clinical Trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial that enrolled 678 children and adolescents aged 4 to 15 across eight countries worldwide (450 in the OT-101 group and 228 in the control group; of which 170 subjects were enrolled in China). The dosing period is three years, and the total study duration is 48 months. The primary endpoint is the percentage of study eyes with myopia progression of 0.75D at Month 36. At Month 36, the percentage of study eyes with myopia progression of 0.75D in the OT-101 group was significantly lower than that in the control group, and the result met the prespecified primary endpoint criteria for the China region of the Phase III Clinical Trial. In terms of safety, the overall incidence of adverse events was comparable to that of the control group, while the incidence of adverse events suspected to be treatment-related was higher than that of the control group, mainly including photophobia, eye pain, and conjunctivitis, which are broadly consistent with the known pharmacological effects of atropine. No unexpected safety signals were identified.