OCUMENSION-B(01477): The new drug marketing registration application for OT-502 has been accepted by the National Medical Products Administration.
Euconvisio Biotech (01477) announces the release of a new drug, OT-502, which treats postoperative inflammation.
OCUMENSION-B(01477) announced that a new drug OT-502 (DEXYCU, dexamethasone implant) for the treatment of postoperative inflammation has recently been accepted for market registration application by the National Medical Products Administration of China.
OT-502 (DEXYCU, dexamethasone implant) is a single-dose sustained-release drug of dexamethasone (a corticosteroid) used for the treatment of postoperative inflammation after cataract surgery. To date, OT-502 is the first and only single-dose sustained-release posterior chamber corticosteroid approved by the US Food and Drug Administration for postoperative inflammation. The company is developing OT-502 as a potential first-in-class treatment for postoperative inflammation related to cataract surgery in China. The Phase III clinical trial of OT502 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical and pharmacokinetic study to evaluate the efficacy and safety of 9% dexamethasone implant in the treatment of postoperative inflammation after cataract surgery, and has reached its primary endpoints in China in April 2024.
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