AffaMed Therapeutics approved for Phase 3 trial in China for DEXTENZA

AffaMed Therapeutics announced that China’s National Medical Products Administration has approved AffaMed’s Clinical Trial Application to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery. In addition, AffaMed is pleased to announce that DEXTENZA has recently been approved in Macau, China for the treatment of ocular itching associated with allergic conjunctivitis. In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix for the development and commercialization of DEXTENZA in Greater China, South Korea, and certain ASEAN markets. DEXTENZA is approved in the U.S. and Macau for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. Following this CTA approval, AffaMed will soon initiate the proposed registrational study in China.