AffaMed Therapeutics Announces Completion of Patient Enrollment in the Real-World Study in China Evaluating the Safety and Efficacy of DEXTENZA® in Cataract Surgery Patients
SHANGHAI,May 31,2023 -- AffaMed Therapeutics ("AffaMed"),a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical,digital and surgical productsthat address critical unmet medical needs in ophthalmological,neurological and psychiatric disorders,today announced the completion of patient enrollment in the Real-World Study ("RWS") conducted in the Boao Lecheng Pilot Zone in Hainan,China,to evaluate the safety and efficacy of DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following cataract surgery.
"We are pleased to announce the completion of enrollment for our Real-World Study in cataract surgery patients," Dr. Dayao Zhao,CEO of AffaMed commented,"This represents a significant milestone for AffaMed in bringing this novel and differentiated treatment option to patients. We look forward to advancing this late-stage program towards registration in mainland China and other Asian markets".
In October 2020,AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix,Inc. (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.
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. This product offers patients significant benefit and convenience vs. current treatments requiring multiple daily administrations of eyedrops.
The purpose of this study is to gather additional supportive evidence for the use of DEXTENZA in a Chinese population. A total of one hundred fourteen (114) patients were treated with DEXTENZA in the RWS. The primary endpoint of the study is the absence of anterior chamber cells in the study eye on Day 14. Topline data from RWS are anticipated in Q3,2023.
In addition,AffaMed recently received Clinical Trial Application (CTA) approval from China's National Medical Products Administration (NMPA) to initiate a Phase 3 registrational (randomized controlled) study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery.
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.
About DEXTENZA
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.
