AffaMed Therapeutics Announces New Drug Approval for DEXTENZA in Macau for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery
AffaMed Therapeutics announced the approval of DEXTENZA in Macau, China, for treating ocular inflammation and pain post-ophthalmic surgery. This approval follows a licensing agreement with Ocular Therapeutix (NASDAQ: OCUL) for its development in Greater China, South Korea, and some ASEAN markets. DEXTENZA is already FDA-approved for similar indications in the U.S. The product is notable as the first sustained-release intracanalicular insert in Macau, allowing for a preservative-free dose of dexamethasone for 30 days with a single administration. Future expansion of indications is planned.
- Approval of DEXTENZA in Macau opens new market opportunities.
- First sustained-release intracanalicular insert in Macau for ocular conditions.
- Potential to expand indications to include allergic conjunctivitis treatment.
- None.
SHANGHAI, April 12, 2022 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, today announced that DEXTENZA has been approved in Macau, China for the treatment of ocular inflammation and pain following ophthalmic surgery. In 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 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, CEO of AffaMed commented: "We are encouraged by the Macau government's policy and efficiency in registering novel therapies based on strong clinical trial data from Ocular's FDA registration trials. Our team is preparing an application to expand the approved indication to include the treatment of ocular itching associated with allergic conjunctivitis. We are looking forward to launching DEXTENZA and providing the product to patients in Macau as soon as possible."
By receiving this approval, DEXTENZA becomes the first sustained-release intracanalicular insert in Macau delivering a preservative-free dose of dexamethasone for up to 30 days with a single administration.
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 and other retinal diseases. OTX-TIC (travoprost intracameral implant) recently began a Phase 2 clinical trial to evaluate the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix has also completed Phase 2 clinical trials for OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Ocular Therapeutix's first product, ReSure Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.
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.
View original content:SOURCE AffaMed Therapeutics
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