AffaMed Therapeutics today announced that DEXTENZA has been approved in Macau, China for the treatment of ocular inflammation and pain following ophthalmic surgery. In 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 currently approved in the U.S. for the treatment of ocular inflammation and pain following ophthalmic surgery and for the treatment of ocular itching associated with allergic conjunctivitis.
Dr. Dayao Zhao, CEO of AffaMed commented: “We are encouraged by the Macau government’s policy and efficiency in registering novel therapies based on strong clinical trial data from Ocular’s FDA registration trials. Our team is preparing an application to expand the approved indication to include the treatment of ocular itching associated with allergic conjunctivitis. We are looking forward to launching DEXTENZA and providing the product to patients in Macau as soon as possible.”
By receiving this approval, DEXTENZA becomes the first sustained-release intracanalicular insert in Macau delivering a preservative-free dose of dexamethasone for up to 30 days with a single administration.