▎Reporting by the WuXi AppTec Content Team

Today (February 19),AffaMed TherapeuticsAffaMed Therapeutics Announces Acceptance of New Drug Application for DEXTENZA by Singapore's Health Sciences Authority, Targeting Indications forTreatment of post-operative inflammation and pain in ophthalmic surgery, and ocular itching associated with allergic conjunctivitisCurrently, the product has been approved in the United States and Macao, China, for the treatment of ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis.

AffaMed Therapeutics is a biopharmaceutical technology company dedicated to developing and commercializing innovative drugs and medical device products to address unmet critical healthcare needs in the field of ophthalmology for patients in Greater China, the Asia-Pacific region, and globally. In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix.AffaMed Therapeutics Obtains Rights to Develop and Commercialize DEXTENZA in Greater China, South Korea, and ASEAN Markets。

According to the news release from AffaMed Therapeutics,DEXTENZA is a preservative-free, sustained-release punctal plug insert that can continuously deliver dexamethasone to the ocular surface for 30 days after a single insertion.Compared with currently conventional eye drops that require multiple administrations daily, this medication can provide significant benefits and convenience to patients.

Currently, AffaMed Therapeutics has launched a registration trial in China to evaluate DEXTENZA compared with a placebo carrier.For the treatment of inflammation and pain after cataract surgerySafety and efficacy, the top-line data of this study is expected to be released in the third quarter of 2024.

Vijay Karwal, CEO of AffaMed Therapeutics, stated: "As the first new drug marketing application submitted by AffaMed Therapeutics, the acceptance of the DEXTENZA new drug marketing application in Singapore marks an important milestone for our company in successfully advancing urgently needed clinical drugs into the Asia-Pacific market through regulatory pathways."DEXTENZA is the leading candidate in AffaMed Therapeutics' innovative and differentiated ophthalmology product pipeline, representing a significant advancement in the treatment of post-operative ocular inflammation and pain, as well as ocular itching associated with allergic conjunctivitis."We look forward to making this product available to patients and clinical healthcare professionals as soon as possible."

[1] AffaMed Therapeutics Announces Acceptance of New Drug Application for DEXTENZA® by Singapore's Health Sciences Authority. Retrieved Feb 19, 2024, from https://www.prnasia.com/story/436912-1.shtml