AffaMed Therapeutics Announces Completion of Patient Enrollment in China Real-World Study Evaluating DEXTENZA® for Safety and Efficacy in Cataract Surgery Patients

ShanghaiMay 29, 2023PR Newswire -- AffaMed Therapeutics, a global innovative biotech company dedicated to developing and commercializing transformative pharmaceuticals, digital therapeutics, and medical device products to address unmet critical medical needs in ophthalmology, neurology, and psychiatry, today announced the completion of patient enrollment in a real-world study (RWS) conducted in Boao Lecheng Pilot Zone, Hainan, China. The study aims to evaluate the safety and efficacy of DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for treating post-operative inflammation and pain following cataract surgery.

"We are pleased to announce the completion of patient enrollment in this real-world study conducted among cataract surgery patients," said Dr. Dayao Zhao, CEO of AffaMed Therapeutics. "This is an important milestone for AffaMed Therapeutics in bringing novel and differentiated treatment options to patients. We will accelerate the registration of this late-stage clinical product in the China and Asian markets.""

In October 2020, AffaMed Therapeutics entered into a licensing 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 in the United States and Macao for treating ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis. AffaMed Therapeutics will initiate registration studies in China as soon as approval is granted.

AffaMed Therapeutics is developing DEXTENZA, the first sustained-release punctal plug insert that is preservative-free. A single insertion can continuously deliver dexamethasone to the ocular surface for 30 days. Compared with conventional eye drops that require multiple daily administrations, DEXTENZA ensures compliance with medication use, providing significant benefits and convenience to patients.

This study aims to provide supportive evidence for the use of DEXTENZA in the Chinese population. A total of 114 DEXTENZA implants were completed, with the primary endpoint being no anterior chamber cells in the study eye on Day 14. The key Real-World Study (RWS) data is expected to be released in the third quarter of 2023.

In addition, the Phase 3 registration (randomized controlled) clinical trial of DEXTENZA has recently been approved to enter the clinical stage in mainland China. This study aims to evaluate the efficacy and safety of DEXTENZA in subjects after ophthalmic surgery.