Ocular Therapeutix’s Dextenza shows efficacy in cataract surgery trial

Ocular Therapeutix’s Dextenza, licensed to AffaMed Therapeutics, a global biotechnology company dedicated to ophthalmological, neurological and psychiatric disorders, showed positive top-line results in the Real-World Study conducted in Hainan, China, to evaluate safety and efficacy 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 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. In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix 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.