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.
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SOURCE AffaMed Therapeutics