AffaMed Therapeutics Reports Positive Top-Line Results From Study Evaluating DEXTENZA

(RTTNews) - Biotechnology company AffaMed Therapeutics announced Tuesday positive top-line results from the Real-World Study conducted in the Boao Lecheng Pilot Zone in Hainan, China, to evaluate the safety and efficacy of DEXTENZA (0.4 mg dexamethasone ophthalmic insert) 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 also 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, Inc. (OCUL) for the development and commercialization of DEXTENZA in Greater China, South Korea, and certain ASEAN markets.

DEXTENZA is approved in the U.S. and MacauSAR for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.