
Innovative Biopharmaceutical Developer
ShanghaiOctober 31, 2023PR Newswire -- AffaMed Therapeutics, a global innovative biopharmaceutical technology company dedicated to developing and commercializing transformative drugs, digital therapies, and medical device products to address unmet critical medical needs of patients in the fields of ophthalmology, neurology, and psychiatry, today announced positive results from a real-world study (RWS) conducted in Boao Lecheng Pilot Zone, Hainan, China. The study aimed to evaluate the safety and efficacy of DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for treating post-operative ocular inflammation and pain following cataract surgery.
""We are pleased to announce positive results from the real-world study in cataract surgery patients," said Dr. Dayao Zhao, CEO of AffaMed Therapeutics. "DEXTENZA has demonstrated significant efficacy in Chinese patients.Good"Safety is an important milestone for AffaMed Therapeutics in advancing the late-stage project registration in mainland China."
In October 2020, AffaMed Therapeutics entered into an exclusive license agreement with Ocular Therapeutix, Inc. ("Ocular", Nasdaq: OCUL) to obtain the rights to develop and commercialize DEXTENZA in Greater China, South Korea, and ASEAN markets. Currently, the product has been approved for use in the United States and Macao.RegionApproved for the treatment of ocular inflammation and pain after ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis.
DEXTENZA is the first preservative-free sustained-release lacrimal punctum plug that delivers dexamethasone to the ocular surface over 30 days after a single insertion. Compared with conventional eye drops that require multiple daily administrations, DEXTENZA ensures compliance in medication use, providing significant benefits and convenience to patients.