Ocumension Therapeutics’ OT-502 Receives NMPA Acceptance for Post-Cataract Inflammation Treatment

Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration (NMPA) in China has accepted its New Drug Application (NDA) for OT-502 (DEXYCU, dexamethasone implant). This ophthalmic new drug is designed to treat postoperative inflammation and is indicated for suppressing inflammation and related complications in patients following cataract surgery. Conventional clinical treatment for this indication typically involves the use of steroid and antibiotic eye drops, which suffer from poor patient compliance. OT-502 utilizes the Verisome drug delivery platform to deliver dexamethasone directly into the anterior chamber of the eye, effectively inhibiting the synthesis and release of inflammatory mediators, thus avoiding the frequent application of topical steroid eye drops. This provides a superior alternative for the management of post-cataract surgery inflammation. OT-502 received FDA approval in the United States on February 9, 2018. The Phase III clinical trial for OT-502 in China achieved its primary endpoints in April 2024, potentially offering a first-in-class therapy for the treatment of post-cataract surgery inflammation in China.- Flcube.com