AffaMed Therapeutics Announces Singapore HSA Acceptance of NDA for DEXTENZA® for Post-Ophthalmic Surgery Inflammation, Pain, and Ocular Itching Associated with Allergic Conjunctivitis

ShanghaiFebruary 19, 2024PR Newswire -- AffaMed Therapeutics, a biopharmaceutical technology company dedicated to developing and commercializing innovative drugs and medical device products to address unmet critical medical needs in the treatment of ophthalmic diseases, today announced that the new drug application for DEXTENZA® for the treatment of post-operative ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis, has been accepted by Singapore's Health Sciences Authority. Currently, the product has been approved in the United States and Macao for the treatment of ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis.

AffaMed Therapeutics is developing DEXTENZA, the first sustained-release punctal plug insert for the ASEAN market and patients in Greater China. It is preservative-free and can continuously release dexamethasone to the ocular surface for 30 days after a single insertion, offering significant benefits and convenience to patients compared to conventional eye drops that require multiple daily applications.

Vijay Karwal, Chief Executive Officer 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 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 healthcare providers as soon as possible."

AffaMed Therapeutics has initiated a registration trial in mainland China to evaluate the safety and efficacy of DEXTENZA compared to a placebo carrier for the treatment of inflammation and pain following cataract surgery. Topline data from this study is expected to be announced in the third quarter of 2024.

In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix, Inc. ("Ocular", Nasdaq: OCUL) to obtain the rights to develop and commercialize DEXTENZA in Greater China, South Korea, and ASEAN markets.

About AffaMed Therapeutics

AffaMed Therapeutics is a biopharmaceutical technology company dedicated to developing and commercializing innovative pharmaceuticals 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. The management team of AffaMed Therapeutics possesses comprehensive expertise and industry experience, having held senior management positions in leading multinational biopharmaceutical companies in China and globally. They have successfully advanced and led efforts in innovative drug discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations.

About DEXTENZA

DEXTENZA Receives FDA Approval for Treating Ocular Inflammation and Pain After Ophthalmic Surgery, as well as Ocular Itching Associated with Allergic Conjunctivitis. As a corticosteroid intracanalicular insert, DEXTENZA is preservative-free and can be non-invasively inserted into the canaliculus on the inner eyelid, providing sustained release of dexamethasone to the ocular surface for 30 days. No removal is required; DEXTENZA will be naturally absorbed and flushed out through the nasolacrimal system.