AffaMed Therapeutics (“AffaMed”), a global clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, today announced the dosing of its first patient in a real-world setting study being conducted in Boao, Hainan, evaluating the safety and efficacy of DEXTENZA (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain post-cataract surgery. In 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix, Inc. (“Ocular”, NASDAQ: OCUL) for the development and commercialization of DEXTENZA in Greater China, South Korea, and the ASEAN markets. DEXTENZA is currently approved in the U.S. for the treatment of ocular inflammation and pain following ophthalmic surgery and for the treatment of ocular itching associated with allergic conjunctivitis.
Dr. Dayao ZHAO, Chief Executive Officer of AffaMed Therapeutics, commented: “We are pleased to be dosing the first patient in Boao, in the real-world study that evaluates the use of DEXTENZA in China, and to support and accelerate registration applications for imported therapies, so that more patients can benefit from the world's leading innovative therapies.”
This prospective, single-arm, real-world study is designed to assess the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain following cataract surgery in approximately 120 patients at the Boao Super Hospital. The study’s primary efficacy endpoint is the absence of anterior chamber cells in the study eye at Day 14, and the key secondary endpoint is the absence of pain in the study eye at Day 8.
“The market for prescription ophthalmology products in China is sizeable, with $5 billion in annual sales and growth exceeding 16% per year (IQVIA),” said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. “AffaMed shares our vision of developing and commercializing innovative ophthalmology products, and we look forward to working with them to bring our innovative therapies to these global markets.”
About AM007 (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.
