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 (NASDAQ: OCUL) 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.

Dr.Dayao Zhao, CEO of AffaMed commented: "We are encouraged by the Chinese regulator's efficiency in approving our application for this novel therapy based on the proposed Phase 3 study design and the totality of the existing registrational trial data previously submitted by our partner Ocular Therapeutix to the U.S. FDA. We are ready to start the Phase 3 trial, and we are looking forward to completing the development of DEXTENZA so that we can bring this novel and differentiated treatment option to patients in China as soon as possible."

AffaMed is developing DEXTENZA to become the first sustained-release intracanalicular insert in China delivering a preservative-free dose of dexamethasone for up to 30 days with a single administration. DEXTENZA offers patients significant benefit in the form of assured compliance, and convenience relative to current treatments requiring multiple administrations of eyedrops per day. 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 purpose of the study is to support and accelerate the registration application for DEXTENZA, and AffaMed anticipates sharing top-line data from this study in Q4 2023.