China’s National Medical Products Administration (NMPA) has approved the clinical trial application (CTA) of AffaMed Therapeutics to initiate a Phase III registrational study in the country to evaluate DEXTENZA in subjects following ophthalmic surgery.
DEXTENZA is being developed to become a sustained-release intracanalicular insert for delivering a preservative-free dexamethasone dose for up to 30 days with one administration.
Designed to assess the efficacy and safety of DEXTENZA, the study will enrol Chinese subjects with ocular inflammation and pain following ophthalmic surgery.
AffaMed and Ocular Therapeutix signed a licensing deal in October 2020 to develop and market DEXTENZA in Greater China, South Korea, and some ASEAN markets.
In addition to treatment of ocular inflammation and pain following ophthalmic surgery, DEXTENZA is approved in the US and Macau for ocular itching associated with allergic conjunctivitis.
AffaMed CEO Dr Dayao Zhao said: “We are encouraged by the Chinese regulator’s efficiency in approving our application for this novel therapy, based on the proposed Phase III study design and the totality of the existing registrational trial data previously submitted by our partner Ocular Therapeutix to the US FDA.
“We are ready to start the Phase III trial, and we are looking forward to completing the development of DEXTENZA so that we can bring this novel and differentiated treatment option to patients in China as soon as possible.”
AffaMed is planning to announce the top-line data from the Phase III study in the fourth quarter of this year.