China-based Ocumension Therapeutics (HKG: 1477) has received approval from the National Medical Products Administration (NMPA) for its drug OT-401 (fluocinolone intravitreal implant) for treating chronic non-infectious uveitis. This marks a significant milestone as the first new drug approved in China based on real-world data (RWD), accelerating its commercialization by approximately 1.5 years.
Approval Basis
The approval was supported by data from 28 patients in a real-world study conducted in Hainan’s Bo’ao Lecheng Pilot Zone and Phase III trial data from overseas. OT-401 is a first-in-class sustained-release intravitreal implant designed to deliver controlled doses of fluocinolone over 36 months, providing continuous therapy for chronic non-infectious uveitis.
Commercialization and Development
Ocumension obtained exclusive rights to develop and commercialize OT-401 in Greater China from EyePoint Corporation in November 2018. The drug, marketed as Yutiq outside China, is the only uveitis therapy approved in the US with up to 36 months of fluocinolone release. Real-world research initiated in December 2020 at Bo’ao Super Hospital and multiple ophthalmic centers nationwide supports the Phase III clinical trial evaluating OT-401’s safety and efficacy.-Fineline Info & Tech
