China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company.
Dextenza’s Development and Benefits
AffaMed is developing Dextenza to become the first sustained-release intracanalicular insert in China. This innovative product delivers a preservative-free dose of dexamethasone for up to 30 days with a single administration. This approach offers significant benefits in terms of patient compliance and convenience compared to current standard treatments, which require multiple administrations of eyedrops per day.
Licensing Deal and Real-World Study
In October 2020, AffaMed struck a licensing deal with Ocular Therapeutix, Inc. (NSDQ: OCUL), securing development and commercialization rights to the drug in Greater China, South Korea, and ASEAN countries. Building on this, in January 2022, AffaMed initiated a Real-World Study in Boao, Hainan, evaluating the safety and efficacy of Dextenza (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain post-cataract surgery. The study aims to support and accelerate the registration application for the product, with AffaMed anticipating the release of top-line data in Q4 2023.-Fineline Info & Tech
