More News
Want to Read Locked Articles?
Already Have an Account?
Register A Corporate Account
A corporate account gives you access to licensed reports and subscriptions, the latest news, a personalized dashboard, and weekly emails with news and data.
Regulators in Singapore Accept NDA from AffaMed for Dextenza
Author: Jennie Crabbe
Shanghai-based AffaMed Therapeutics announced Feb. 19 that the Singapore Health Sciences Authority had accepted its new drug application (NDA) for Dextenza (0.4 mg dexamethasone intracanalicular insert) for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
Dextenza delivers a preservative-free dose of dexamethasone for up to 30 days with a single administration. The insert resorbs and exits the nasolacrimal system without the need for removal.
Ocular Therapeutix secured US FDA approval for Dextenza for postsurgical pain in 2018 and inflammation in 2019. Approval for allergic ocular itching was added in October 2021.
The Bedford, Massachusetts, company reported Q3-2023 net product revenue for Dextenza of $15.0 million, up 26 percent from. $11.9 million in Q3-2022.
Ocular Therapeutix licensed Dextenza to AffaMed in 2020 for the Greater China, South Korea, and ASEAN markets. AffaMed paid $12 million up front. Ocular Therapeutix is eligible to receive development, regulatory, and commercial milestone payments and clinical development support payments of up to $91 million, as well as royalties from future product sales in the low teens to low 20 percent range.
AffaMed is conducting a pivotal clinical trial in China to evaluate Dextenza vs. placebo for inflammation and pain following cataract surgery. The company expects topline data in Q3-2024.
