ABVC BioPharma, Inc. today announced that the Vitrargus® Phase II study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) on May 15, 2023.
FREMONT, CA, May 22, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, central nervous system (CNS) disorders, and ophthalmology, today announced that the Vitrargus® Phase II study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) on May 15, 2023.
Early clinical studies indicate that Vitargus® has unique properties that could eliminate the need for patients to remain face-down after retinal detachment and vitreous hemorrhage surgery, as well as significantly improve patient comfort and visual acuity during the surgical recovery period compared to currently available products. The objective of the Phase II study entitled “A Perspective Multi-Site Open-Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)” is to demonstrate the safety and efficacy of Vitargus® for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. The Phase II study will enroll at least forty patients and will be conducted in both Australia and Thailand.
“We are extremely excited to receive the approval from St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) to conduct the Phase II study at Sydney Eye Hospital,” said Dr. Howard Doong, Chief Executive Officer of the Company. “Sydney Eye Hospital will begin to recruit patients shortly under the direction of Professor Matthew Simunovic, Director, Chair Research Committee, joining the three other clinical sites in Thailand and Australia.”
About ABVC BioPharma
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III.
Forward-Looking Statements
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Contact:
Tom Masterson
Email: tmasterson@allelecomms.com
