The board of directors of Ocumension Therapeutics announced that, OT-502 (DEXYCU, dexamethasone implant), a new drug for the treatment of postoperative inflammation indication, has successfully achieved the expected primary efficacy endpoints of its phase III clinical trial, i.e., the treatment group receiving the dexamethasone implant exhibited a notably higher proportion of subjects with anterior chamber cells clearing (ACC grade 0) compared to the placebo group by day 8, demonstrating the safety and efficacy of the product in managing post- cataract inflammation. The Company expects to submit the new drug application (NDA) of OT-502 to the Center for Drug Evaluation of National Medical Products Administration of China in the near future. OT-502 (dexamethasone implant) is a single-dose, sustained-release solution of dexamethasone, a corticosteroid, for the treatment of postoperative inflammation.

To date, OT-502 is the first and only single-dose, sustained-release intracameral steroid for the treatment of postoperative inflammation that was approved by the United States Food and Drug Administration. The Group is developing OT-502 as a potential first-in-class treatment for postoperative inflammation associated with cataract surgery in China. The phase III clinical trial of OT-502 is designed to be a randomized, double-masked, placebo-controlled, parallel-group, multi-center clinical and pharmacokinetic study to evaluate the efficacy and safety of 9% dexamethasone implant in the treatment of post-cataract surgery inflammation, which has completed the patient enrollment in China in November 2023.