OCUMENSION-B (01477.HK): OT-101 Phase III meets China endpoint
- The trial was a multicentre, randomised, double-blind, placebo-controlled, parallel-group study with 450 patients on OT-101 and 228 controls, of whom 170 were enrolled in China.
- Dosing lasted three years within a 48-month study, with the primary endpoint being the percentage of study eyes showing at least 0.75D myopia progression at month 36.
NewTimeSpace News: On 20 October 2026, Ocumension Therapeutics (stock code: 01477) announced topline 36-month primary analysis results from the global Phase III trial of OT-101, its self-developed 0.01% atropine sulfate eye drops, with the share of study eyes showing at least 0.75D myopia progression significantly lower than the placebo arm, meeting the prespecified endpoint for China.
The randomised, double-blind, placebo-controlled trial enrolled 678 children and adolescents aged 4 to 15 across eight countries, 450 in the OT-101 group and 228 in the control group, including 170 in China, with three years of dosing in a 48-month study. Overall adverse events were similar to the control group, while suspected treatment-related events, mainly photophobia, eye pain and conjunctivitis, were higher and consistent with atropine's known pharmacology. The company said the data are preliminary and registration plans depend on subgroup analyses and regulator talks.
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