AffaMed Therapeutics Receives Approval from Singapore's HSA for DEXTENZA® New Drug Application, Targeting Ocular Inflammation, Pain Post-Ophthalmic Surgery, and Allergic Conjunctivitis Itching
20 February 2024
AffaMed Therapeutics, a prominent biotechnology company specializing in developing and commercializing innovative pharmaceutical and surgical products for unmet needs in ophthalmology, has made a significant announcement. The Singapore Health Sciences Authority (HSA) has officially accepted its New Drug Application (NDA) for DEXTENZA® (0.4 mg dexamethasone ophthalmic insert), intended for treating ocular inflammation and pain after ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis. DEXTENZA has already gained approval in the U.S. and is listed in Macau for these indications.
DEXTENZA is a breakthrough as the first sustained-release intracanalicular insert for patients in ASEAN countries and Greater China. With just one administration, this product delivers a preservative-free dose of dexamethasone for up to 30 days, offering significant benefits over current multi-administration eye-drop treatments.
AffaMed, emphasized the importance of this milestone, highlighting DEXTENZA's pivotal role in their ophthalmology pipeline. He anticipates swift availability for patients and physicians post-regulatory approval, underlining its potential in improving post-surgical care and managing allergic conjunctivitis symptoms.
AffaMed has initiated a key trial in Mainland China to evaluate DEXTENZA's safety and efficacy compared to a placebo vehicle in treating inflammation and pain after cataract surgery. Topline data from this trial is expected in Q3 2024.
DEXTENZA, approved by the U.S. FDA, is designed to address ocular inflammation and pain after ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis. Positioned as a corticosteroid intracanalicular insert, DEXTENZA is strategically placed in the punctum and canaliculus, delivering dexamethasone to the ocular surface for up to 30 days without preservatives. Its unique design allows for resorption and exit through the nasolacrimal system, eliminating the need for removal procedures.
Source: prnewswire.com