Okvision's new drug for the treatment of inflammation after cataract surgery was approved for Phase 3 clinical trials

Text|Pharmaceutical Mission Hills

On September 14, Ou Kangweishi issued an announcement stating that one of its main drug candidates, OT-502 (Dexycu), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration to carry out the treatment of post-cataract inflammation in China.

Inflammation is a common symptom after cataract surgery.

OT-502 is a new, biodegradable, single-injection slow-release anti-inflammatory drug, which is 9% dexamethasone implant

Public information shows that OT-502 can release the active ingredient dexamethasone immediately after injection to exert its anti-inflammatory effect.

From the perspective of the mechanism of action, OT-502 can use the drug delivery platform Verisome to deliver dexamethasone to the anterior chamber, directly inhibiting the synthesis and release of inflammatory mediators in the anterior chamber

The OT-502 approved in China is a randomized, double-blind, placebo-controlled, parallel-group, multi-center phase 3 clinical study on the effectiveness and safety of OT-502 in the treatment of postoperative cataract inflammation

It is worth mentioning that, as a clinically urgently needed drug, OT-502 has been qualified for pilot sales in Hainan Boao Lecheng Super Hospital, and has completed the first patient injection in mainland China; at the same time, it has also been approved by CDE to be launched in Boao Lecheng Real world research

Reference

[1] Voluntary announcement that the company's sixth product has entered phase III clinical trials-OT-502 (DEXYCU) was approved by the Center for Drug Evaluation to carry out phase III clinical trials in China.