Ocumension Therapeutics announced that a phase III clinical trial authorization for initiating a randomized, double-masked, placebo-controlled, parallel-group, multicenter clinical trial for OT-101-S, a self-developed product of the Group, has recently been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China. OT-101-S (0.01% and 0.05% atropine sulfate eye drop) is a low-concentration (0.01% and 0.05%) atropine sulfate eye drop developed by the Group to retard, or slow down, the progression of myopia in children. The instability of atropine sulfate solutions under physiological (neutral) pH
conditions has long been a technical barrier towards commercialization. Studies show that, as compared to the high-concentration (0.5%-1%) atropine sulfate eye drop which has frequently reported adverse events including photophobia and blurred vision, low-concentration atropine sulfate eye drop has demonstrated good tolerability, safety and efficacy results. As compared to OT-101, which is designed to contain two chambers of atropine sulfate lyophilized powder and solvent for each dosage unit, OT-101-S is designed to contain two chambers of atropine sulfate concentrated solution and diluted solution for each dosage unit, thus leading to a higher level of
convenience for the storage and usage of atropine sulfate. The Group believes OT-101-S will solve the instability of atropine sulfate solutions under physiological (neutral) pH conditions and thus become a reliable treatment method for myopia in children.