AffaMed Therapeutics Announces First Patient Dosed in China Phase 3 Registration Study of DEXTENZA® for Post-Ophthalmic Surgery Inflammation and Pain

ShanghaiSeptember 20, 2023PR Newswire -- AffaMed Therapeutics, a global innovative biopharmaceutical technology company dedicated to developing and commercializing innovative drugs, digital therapies, and medical device products to meet the critical unmet medical needs of patients in the fields of ophthalmology, neurology, and psychiatry, announced today that the domestic registration Phase 3 clinical study evaluating the efficacy and safety of DEXTENZA (dexamethasone ophthalmic insert, 0.4 mg) for ophthalmic postoperative use has completed the first patient dosing 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 in the United States and Macao for the treatment of ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis.

Dr. Da Yao Zhao, CEO of AffaMed Therapeutics, stated: "We are very pleased to initiate the Phase 3 registration study of DEXTENZA in China. We believe this new therapy can significantly improve the postoperative treatment experience for cataract patients, and our goal is to bring this novel, differentiated treatment option to Chinese patients as soon as possible."

AffaMed Therapeutics is developing DEXTENZA, the first preservative-free dexamethasone sustained-release punctal plug insert. 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 post-operative medication adherence and provides significant benefits and convenience to patients.

The Phase 3 clinical trial of DEXTENZA in China is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. This study plans to enroll 249 subjects undergoing cataract phacoemulsification combined with intraocular lens implantation to evaluate the safety and efficacy of DEXTENZA in treating post-operative ocular inflammation and pain.

For more information about this study (CTR20232404), please visitwww.chinadrugtrials.org.cn.

Previously, AffaMed Therapeutics launched a real-world study in Boao, Hainan, in January 2022 to evaluate the safety and efficacy of DEXTENZA in treating post-cataract surgery ocular inflammation and pain. This study aims to support and expedite the registration application of DEXTENZA in mainland China, with results expected to be released in the fourth quarter of 2023.