The Singapore Health Sciences Authority (HSA) has accepted the new drug application (NDA) for AffaMed Therapeutics’ DEXTENZA (0.4 mg dexamethasone ophthalmic insert) to treat ocular inflammation and pain.
The treatment is indicated following ophthalmic surgical procedures and for ocular itching linked to allergic conjunctivitis.
This marks a significant milestone for the company as it seeks to expand the reach of DEXTENZA, which is already approved in the US and listed in Macau for similar indications.
DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the punctum and canaliculus of the eye.
It offers dexamethasone to the ocular surface for up to 30 days without the use of preservatives.
The insert's unique feature is its reabsorption, enabling it to exit the nasolacrimal system on its own.
AffaMed is progressing the development of DEXTENZA as the first physician-administered, sustained-release intracanalicular insert available to patients in ASEAN countries and Greater China.
The convenience of a single administration that delivers a preservative-free dose of dexamethasone over 30 days provides significant benefits over existing therapies, which typically require multiple daily eye-drop applications.
The company has also initiated a registrational trial to assess the efficacy and safety of DEXTENZA against a placebo vehicle for treating inflammation and pain post-cataract surgery in mainland China.
Topline data from this trial is anticipated in the third quarter of 2024.
AffaMed entered a licensing agreement with Ocular Therapeutix in October 2020 in a strategic move to broaden its market.
The agreement covers the development and commercialisation of DEXTENZA in South Korea, Greater China and some ASEAN [Association of South East Asian Nations] markets.
AffaMed CEO Vijay Karwal stated: “As the first NDA filing by AffaMed, the acceptance of our DEXTENZA NDA in Singapore represents an important milestone in our company’s journey to successfully advance much-needed therapeutic candidates through regulatory pathways across multiple regions in Asia.
“DEXTENZA is the lead candidate in AffaMed’s innovative and differentiated ophthalmology pipeline and represents an important advancement in the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.”
In September 2023, the company received approval from China’s National Medical Products Administration for a clinical trial application of risuteganib (Luminate) to treat intermediate dry age-related macular degeneration.
