AffaMed Therapeutics Announces DEXTENZA Approved for Marketing in Macau for Post-Ophthalmic Surgery Inflammation and Pain

For the treatment of ocular inflammation and pain after ophthalmic surgery

Shanghai, April 13, 2022PR Newswire -- AffaMed Therapeutics, a clinical-stage biopharmaceutical company dedicated to addressing global unmet medical needs in ophthalmology, neurology, and psychiatry, today announced that DEXTENZA has been approved for marketing in Macao, 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) to gain the rights to develop and commercialize DEXTENZA in Greater China, South Korea, and ASEAN markets. Currently, DEXTENZA is approved by the U.S. Food and Drug Administration (FDA) for the treatment of ocular inflammation and pain following ophthalmic surgery, as well as for ocular itching associated with allergic conjunctivitis.

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, stated: "We are deeply encouraged by the policy and efficiency of Macao's regulatory authorities in recognizing FDA-approved clinical trial data from Ocular Therapeutix for new drug registration. Our team is also actively preparing to submit an application to add the indication for treating allergic conjunctivitis-related eye itching. We look forward to DEXTENZA being launched in Macao as soon as possible to benefit local patients."

After gaining approval for marketing, DEXTENZA has become the first lacrimal duct insert in Macao used for treating ocular inflammation and pain following ophthalmic surgery. DEXTENZA is preservative-free and can provide a sustained release of dexamethasone to the ocular surface for 30 days after a single implantation.