AffaMed Therapeutics, licensee of DEXTENZA in Certain Asian Markets, Doses Their First Patient in Clinical Trial Evaluating the Safety and Efficacy of DEXTENZA in China in Cataract Surgery Patients
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that AffaMed Therapeutics dosed its first patient in a real-world setting study being conducted in China 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, Ocular entered into a licensing agreement with AffaMed Therapeutics 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 Bo’ao, 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 trial 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 Bo’ao Super Hospital. The trial’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.”
Under the terms of the agreement with AffaMed, Ocular Therapeutix has been paid an upfront payment of $12 million and is eligible to receive development, regulatory and commercial milestone payments and clinical development support payments of up to an additional $91 million in the aggregate, as well as royalties from future product sales. Royalties are tiered and will range from the low teens to low twenty percent range. In return, Ocular Therapeutix has agreed to grant AffaMed exclusive rights to develop and commercialize DEXTENZA for the treatment of post-surgical inflammation and pain following ophthalmic surgery and ocular itching in patients with allergic conjunctivitis, and OTX-TIC for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan; South Korea; and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam). Ocular Therapeutix retains the right to develop and commercialize DEXTENZA and OTX-TIC in all other global markets.