SHANGHAI, Feb. 19,
2024 /PRNewswire/ -- 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.
View original
content:https://www.prnewswire.com/news-releases/affamed-therapeutics-announces-new-drug-application-acceptance-by-singapore-health-sciences-authority-hsa-for-dextenza-for-treatment-of-ocular-inflammation-and-pain-following-ophthalmic-surgery-and-ocular-itching-associated-wi-302064649.html
SOURCE AffaMed Therapeutics