Gelonghui, April 15 | Okanvision Bio-B (01477.HK) announced that OT-502 (DEXYCU, dexamethasone implant), a new drug for treating post-operative inflammatory indications, has successfully reached the expected main efficacy endpoint of its phase III clinical trial. That is, on day 8, the proportion of subjects with anterior atrial atrial cell clearance (ACC grade 0) in the treatment group with dexamethasone implants was significantly higher than the placebo group, proving that this product is safe and effective in controlling inflammation after cataract surgery. The company expects to submit an OT-502 new drug application to the Drug Evaluation Center of the China National Drug Administration in the near future.
OT-502 (dexamethasone implant) is a single-dose, sustained-release drug of dexamethasone (a corticosteroid) used to treat inflammation after cataract surgery. To date, OT-502 is the first and only single-dose, sustained-release, post-atrial steroid approved by the US Food and Drug Administration for post-operative inflammation. The Group is developing OT-502 as a potential first-of-its-kind treatment for post-operative inflammation associated with cataract surgery in China. The phase III clinical trial of OT-502 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical and pharmacokinetic study to evaluate the efficacy and safety of 9% dexamethasone implants in treating inflammation after cataract surgery. Patients were enrolled in China in November 2023.