AffaMed Therapeutics Announces Approval to Initiate a Phase 3 Registrational Clinical Trial in Mainland China for DEXTENZA® for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery

2023-04-17

临床1期临床2期上市批准临床3期引进/卖出

SHANGHAI, April 17, 2023 /PRNewswire/ -- 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 ophthalmological, neurological and psychiatric disorders, today announced that China's National Medical Products Administration (NMPA) has approved AffaMed's Clinical Trial Application (CTA) to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery. In addition, AffaMed is pleased to announce that DEXTENZA has recently been approved in Macau, China for the treatment of ocular itching associated with allergic conjunctivitis. In October 2020, AffaMed Therapeutics entered into a licensing 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. Following this CTA approval, AffaMed will soon initiate the proposed registrational study in China.

Dr.Dayao Zhao, CEO of AffaMed commented: "We are encouraged by the Chinese regulator's efficiency in approving our application for this novel therapy based on the proposed Phase 3 study design and the totality of the existing registrational trial data previously submitted by our partner Ocular Therapeutix to the U.S. FDA. We are ready to start the Phase 3 trial, and we are looking forward to completing the development of DEXTENZA so that we can 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. In January 2022, AffaMed initiated a Real World Study 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. The purpose of the study is to support and accelerate the registration application for DEXTENZA, 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.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets include: OTX-TKI (axitinib intravitreal implant), currently in Phase 1 clinical trials for the treatment of wet AMD AMD and diabetic retinopathy; OTX-TIC (travoprost intracameral implant), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease, both of which have completed Phase 2 clinical trials.

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.

Please see full Prescribing and Safety Information at www.DEXTENZA.com.

SOURCE AffaMed Therapeutics Ltd.