AffaMed Therapeutics said that the Singapore Health Sciences Authority has accepted its New Drug Application or NDA for Dextenza (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
Dextenza is approved in the U.S. and listed in Macau for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
AffaMed is developing Dextenza, the first physician-administered sustained-release intracanalicular insert available to patients in ASEAN countries and Greater China.
AffaMed has initiated a registrational trial in Mainland China to evaluate the safety and efficacy of Dextenza versus a placebo vehicle in the treatment of inflammation and pain following cataract surgery, and anticipates sharing data from the study in third-quarter 2024.
In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix Inc. (OCUL) for the development and commercialization of Dextenza in Greater China, South Korea, and certain ASEAN markets.
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