SHANGHAI, Oct. 31,
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, announced
positive top-line results from the Real-World Study conducted in
the Boao Lecheng Pilot Zone in Hainan,
China, to evaluate the safety and efficacy of DEXTENZA® (0.4
mg dexamethasone ophthalmic insert) for the treatment of ocular
inflammation and pain following cataract surgery.
- The trial met its primary endpoint, with Dextenza
demonstrating a significant reduction of ocular inflammation as
measured by the absence of anterior chamber cells (i.e. score of
"0") in the study eye on Day 14 after cataract surgery.
- The trial also met its secondary endpoint, demonstrating a
significant reduction of ocular pain on Day 8.
- Dextenza was well-tolerated and had a favorable safety profile
consistent with all prior trials.
"We are thrilled to announce the positive topline results from
our Real-World Study in cataract surgery patients," Dr.
Dayao Zhao, CEO of AffaMed
commented, "Dextenza shows great efficacy and safety in Chinese
patients, and this is a significant milestone for AffaMed in
advancing this late-stage program towards registration in Mainland
China".
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. DEXTENZA is approved in the U.S. and
Macau SAR for the treatment of ocular inflammation
and pain following ophthalmic surgery, and ocular itching
associated with allergic conjunctivitis.
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. This
product offers patients significant benefits and convenience vs.
current standard of care requiring multiple daily administrations
of eyedrops.
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 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.
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SOURCE AffaMed Therapeutics Ltd.