AffaMed Therapeutics (“AffaMed”), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmologic, neurological and psychiatric disorders, today announced that the first patient has been treated in the Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA (0.4 mg dexamethasone ophthalmic insert) in subjects following ophthalmic surgery. In October 2020, AffaMed Therapeutics entered into an exclusive license 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.
Dr. Dayao Zhao, CEO of AffaMed commented: "We are excited to initiate the Phase 3 registration study in Mainland China for DEXTENZA. We believe this novel therapy has the potential to significantly improve the post-operative treatment experience for patients following cataract surgery, and we aim to 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 after ocular surgery.
This is a prospective, randomized, double-masked, placebo-controlled, parallel-group, multicenter clinical study to evaluate the safety and efficacy of DEXTENZA (dexamethasone ophthalmic insert) versus placebo vehicle in the treatment of inflammation and pain in subjects who have undergone ocular surgery. A total of 249 subjects who have undergone cataract phacoemulsification with intraocular lens implantation will be enrolled to evaluate the safety and efficacy of DEXTENZA in the treatment of ocular inflammation and pain following cataract surgery.
More information on the study (CTR20232404) is available at www.chinadrugtrials.org.cn.
As previously announced, in January 2022, AffaMed initiated a Real-World Study in Boao, Hainan, evaluating the safety and efficacy of DEXTENZA 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 in Mainland China, and AffaMed anticipates sharing top-line data from this study in Q4 2023.
About AffaMed Therapeutics
AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.
DEXTENZA is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.