AffaMed Therapeutics Announced Positive Top-Line Results from Real-World Study in China Evaluating the Safety and Efficacy of DEXTENZA® in Patients after Cataract Surgery

Rhea-AI Summary

AffaMed Therapeutics announced positive top-line results from a Real-World Study conducted in China evaluating the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain following cataract surgery. The trial met its primary and secondary endpoints, demonstrating a significant reduction in inflammation and pain. DEXTENZA was well-tolerated and had a favorable safety profile. AffaMed is developing DEXTENZA to become the first sustained-release intracanalicular insert in China.

Positive

• The Real-World Study conducted by AffaMed Therapeutics in China showed positive results for DEXTENZA in treating ocular inflammation and pain after cataract surgery.
• DEXTENZA demonstrated a significant reduction in ocular inflammation as measured by the absence of anterior chamber cells on Day 14 after surgery.
• The trial also showed a significant reduction in ocular pain on Day 8 after surgery.
• DEXTENZA had a favorable safety profile consistent with previous trials.
• This is a significant milestone for AffaMed in advancing the late-stage program of DEXTENZA towards registration in Mainland China.

Negative

• None.

SHANGHAI, Oct. 31, 2023 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, announced positive top-line results from the Real-World Study conducted in the Boao Lecheng Pilot Zone in Hainan, China, to evaluate the safety and efficacy of DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following cataract surgery.

• The trial met its primary endpoint, with Dextenza demonstrating a significant reduction of ocular inflammation as measured by the absence of anterior chamber cells (i.e. score of "0") in the study eye on Day 14 after cataract surgery.
• The trial also met its secondary endpoint, demonstrating a significant reduction of ocular pain on Day 8.
• Dextenza was well-tolerated and had a favorable safety profile consistent with all prior trials.

"We are thrilled to announce the positive topline results from our Real-World Study in cataract surgery patients," Dr. Dayao Zhao, CEO of AffaMed commented, "Dextenza shows great efficacy and safety in Chinese patients, and this is a significant milestone for AffaMed in advancing this late-stage program towards registration in Mainland China".

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. DEXTENZA is approved in the U.S. and Macau SAR for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.

AffaMed is developing DEXTENZA to become the first sustained-release intracanalicular insert in China delivering a preservative-free dose of dexamethasone for up to 30 days with a single administration. This product offers patients significant benefits and convenience vs. current standard of care requiring multiple daily administrations of eyedrops.

About AffaMed Therapeutics

AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China 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 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 Ltd.

FAQ

What did AffaMed Therapeutics announce?

AffaMed announced positive top-line results from a Real-World Study evaluating the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain following cataract surgery.

What were the results of the study?

The study met its primary endpoint, showing a significant reduction in ocular inflammation. It also met its secondary endpoint, demonstrating a significant reduction in ocular pain.

What is DEXTENZA?

DEXTENZA is a pharmaceutical product developed by AffaMed Therapeutics for the treatment of ocular inflammation and pain following ophthalmic surgery.

What is the significance of these results?

The positive results from the Real-World Study are a significant milestone for AffaMed in advancing the late-stage program of DEXTENZA towards registration in Mainland China.

What is the goal of AffaMed in developing DEXTENZA?

AffaMed aims to develop DEXTENZA as the first sustained-release intracanalicular insert in China, delivering a preservative-free dose of dexamethasone for up to 30 days with a single administration.