AffaMed Therapeutics (“AffaMed”), a biotechnology company dedicated to developing and commercializing transformative pharmaceutical, and surgical products that address critical unmet medical needs in ophthalmology, today announced that the Singapore Health Sciences Authority (HSA) has accepted its New Drug Application (NDA) for DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. DEXTENZA is approved in the U.S. and listed in Macau for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
AffaMed is developing DEXTENZA, the first physician-administered sustained-release intracanalicular insert available to patients in ASEAN countries and Greater China. DEXTENZA delivers a preservative-free dose of dexamethasone for up to 30 days with a single administration, thereby offering patients significant benefit and convenience versus current treatments which require multiple administrations of eye-drops per day.
"As the first NDA filing by AffaMed, the acceptance of our DEXTENZA NDA in Singapore represents an important milestone in our company’s journey to successfully advance much-needed therapeutic candidates through regulatory pathways across multiple regions in Asia," said Vijay Karwal, Chief Executive Officer of AffaMed. “DEXTENZA is the lead candidate in AffaMed’s innovative and differentiated ophthalmology pipeline and represents an important advancement in the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. We look forward to bringing its benefits to patients and physicians as quickly as possible.”
AffaMed has initiated a registrational trial in Mainland China to evaluate the safety and efficacy of DEXTENZA versus a placebo vehicle in the treatment of inflammation and pain following cataract surgery, and anticipates sharing topline data from this study in Q3 2024.
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.
About AffaMed Therapeutics
AffaMed Therapeutics is a biotechnology company focused on developing and commercializing transformative pharmaceutical, and surgical products that address critical unmet medical needs in ophthalmology for patients in Greater China, Asia 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 U.S. 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.
