AffaMed Therapeutics Announces New Drug Application Acceptance by Singapore Health Sciences Authority (HSA) for DEXTENZA® for Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery, and Ocular Itching Associated with Allergic Conjunctivitis

Rhea-AI Summary

AffaMed Therapeutics announces acceptance of DEXTENZA NDA by Singapore Health Sciences Authority for treating ocular inflammation and pain following ophthalmic surgery.

Pharmaceutical Analyst

The acceptance of the New Drug Application (NDA) for DEXTENZA by the Singapore Health Sciences Authority is a significant regulatory milestone for AffaMed Therapeutics. This development can potentially expedite the drug's entry into the ASEAN market, which may result in increased revenue streams for the company. Given that DEXTENZA offers a more convenient treatment option with its sustained-release mechanism, it is poised to capture market share from traditional eye-drop treatments that require more frequent administration.

From an industry perspective, the adoption of novel drug delivery systems like DEXTENZA's intracanalicular insert is indicative of a broader trend towards patient-centric solutions that enhance compliance and outcomes. AffaMed's strategic partnership with Ocular Therapeutix, Inc. for DEXTENZA's development and commercialization in key Asian markets also suggests potential for expanded market penetration and diversified risk.

Market Research Analyst

The ophthalmology sector in Asia is rapidly growing due to increasing prevalence of eye-related diseases and a growing middle class able to afford advanced treatments. AffaMed's NDA acceptance in Singapore positions the company advantageously in this expanding market. The company's ability to navigate the regulatory landscape in multiple Asian jurisdictions will be crucial in determining the speed and success of DEXTENZA's market adoption.

Moreover, the initiation of a registrational trial in Mainland China is a strategic move, considering China's large patient population and increasing healthcare expenditure. The outcome of this trial and subsequent topline data release in Q3 2024 will be critical in influencing investor sentiment and could impact AffaMed's stock valuation, depending on the trial's success or failure.

Healthcare Economist

The economic implications of introducing a drug like DEXTENZA to the ASEAN and Greater China markets are multifaceted. On one hand, the reduction in the frequency of administration compared to traditional eye drops could lead to lower overall healthcare costs due to improved patient adherence and potentially fewer complications. On the other hand, the pricing strategy for DEXTENZA will be an important factor in determining its affordability and adoption rate, especially in price-sensitive markets.

It is also noteworthy that the collaboration with Ocular Therapeutix may lead to shared development costs and resources, which could improve the financial efficiency of bringing DEXTENZA to market. The economic impact of this drug will ultimately depend on its market uptake, competitive pricing and the ability to displace existing treatments.

SHANGHAI, Feb. 19, 2024 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a biotechnology company dedicated to developing and commercializing transformative pharmaceutical, and surgical products that address critical unmet medical needs in ophthalmology, today announced that the Singapore Health Sciences Authority (HSA) has accepted its New Drug Application (NDA) for DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. DEXTENZA is approved in the U.S. and listed in Macau for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.

AffaMed is developing DEXTENZA, the first physician-administered sustained-release intracanalicular insert available to patients in ASEAN countries and Greater China. DEXTENZA delivers a preservative-free dose of dexamethasone for up to 30 days with a single administration, thereby offering patients significant benefit and convenience versus current treatments which require multiple administrations of eye-drops per day.

"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," said Vijay Karwal, Chief Executive Officer of AffaMed. "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. We look forward to bringing its benefits to patients and physicians as quickly as possible."

AffaMed has initiated a registrational trial in Mainland China to evaluate the safety and efficacy of DEXTENZA versus a placebo vehicle in the treatment of inflammation and pain following cataract surgery, and anticipates sharing topline data from this study in Q3 2024.

In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix, Inc. (NASDAQ: OCUL) for the development and commercialization of DEXTENZA in Greater China, South Korea, and certain ASEAN markets.

About AffaMed Therapeutics
AffaMed Therapeutics is a biotechnology company focused on developing and commercializing transformative pharmaceutical, and surgical products that address critical unmet medical needs in ophthalmology for patients in Greater China, Asia and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.

About DEXTENZA
DEXTENZA is U.S. FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

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SOURCE AffaMed Therapeutics

What is the New Drug Application (NDA) accepted by the Singapore Health Sciences Authority (HSA) for AffaMed Therapeutics?

The NDA accepted is for DEXTENZA (0.4 mg dexamethasone ophthalmic insert) for treating ocular inflammation, pain after ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.

What is the significance of the acceptance of the NDA for DEXTENZA by the Singapore Health Sciences Authority?

The acceptance represents a crucial milestone for AffaMed in advancing therapeutic candidates in Asia and brings innovative treatment options for ophthalmic conditions to patients.

What is the unique feature of DEXTENZA developed by AffaMed?

DEXTENZA is a sustained-release intracanalicular insert that delivers preservative-free dexamethasone for up to 30 days with a single administration, offering convenience and benefits over traditional eye-drop treatments.

Which company did AffaMed Therapeutics partner with for the development and commercialization of DEXTENZA?

AffaMed partnered with Ocular Therapeutix, Inc. (NASDAQ: OCUL) for the development and commercialization of DEXTENZA in Greater China, South Korea, and certain ASEAN markets.

What trial has AffaMed initiated in Mainland China related to DEXTENZA?

AffaMed has initiated a registrational trial in Mainland China to evaluate the safety and efficacy of DEXTENZA versus a placebo vehicle in the treatment of inflammation and pain following cataract surgery.