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Singapore HSA accepts AffaMed’s NDA for ocular treatment
License out/inNDADrug Approval
DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the punctum and canaliculus of the eye. Credit: 4 PM production/Shutterstock.com.
DEXTENZAapore 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 linAffaMed Therapeuticsunctivitis.ocular inflammationpain
This marks a significant milestone for the company as it seeks to expand theocular itchingENZA, whichallergic conjunctivitis the US and listed in Macau for similar indications.
DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the puDEXTENZAd canaliculus of the eye.
DEXTENZAs dexamethasone to the ocular surface for up to 30 days without the use of preservatives.
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The insert’s unique feature is its reabsorption, enabling it to exit the nasolacrimal system on its own.
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.
AffaMed entered a licensing agreement with Ocular Therapeutix in October 2020 in a stdexamethasoneto broaden its market.
The agreement covers the development and commercialisation of DEXTENZA in South Korea, GreaDEXTENZAa and some ASEAN [Association of South Einflammationtionspainrkets.cataract
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.
AffaMedZA is the lead candidate in AffaMed’Ocular Therapeutixifferentiated 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 DEXTENZA Medical Products Administration for a clinical trial application of risuteganib (Luminate) to treat intermediate dry age-related macular degeneration.
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