Zhitong Finance App News, Okanvision Bio-B (01477) announced that OT-101 (0.01% atropine sulfate eye drops) is a low-concentration (0.01%) atropine eye drops independently developed by the Group to slow or slow the progression of myopia in children and adolescents. However, the instability of low-concentration atropine solutions has long been a technical obstacle to commercialization. OT-101 uses an innovative sealed split device with an exclusive design to solve the stability problem of low concentration atropine solutions in a neutral environment. The appropriate pH value also improves patients' comfort and medication compliance.
The board of directors of the company hereby announces that the Group recently received the top line results of the 36th month of the global multi-center phase III clinical trial (phase III clinical trial) of OT-101. The phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial. 678 children and adolescents aged 4 to 15 (450 in the OT-101 group and 228 in the control group; 170 participants were enrolled in China) in eight countries around the world. The administration period was three years, and the total study time was 48 months. The primary endpoint was the percentage of study eyes with ≥0.75D myopia progression at month 36.
At month 36, the OT-101 group showed a significantly lower percentage of myopia progression than 0.75D compared to the control group. This result met the pre-established primary endpoint criteria for the phase III clinical trial in China.
In terms of safety, the overall incidence of adverse events was similar to that of the control group, while the incidence of suspected treatment-related adverse events was higher than that of the control group, mainly photophobia, eye pain, and conjunctivitis, which are generally consistent with the known pharmacological effects of atropine. No unexpected safety signals were found.