ABVC BioPharma (ABVC) Announces Vitargus Phase II Study Plan Approved by HREC in Australia
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ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that its Vitrargus Phase II study plan was approved by the Australian Bellberry Human Research Ethics Committee (HREC) on September 29, 2022. Subsequently, a Clinical Trial Notification (CTN) was submitted to the Australian Therapeutic Goods Administration (TGA) for the initiation of the study in Australia.
Early clinical studies indicate that Vitargus has unique properties that eliminate the need for positioning patients face-down post-surgery and result in significantly greater patient comfort and visual acuity during surgical recovery than 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 effectiveness of Vitargus for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. The Phase II study will be conducted in Thailand as well as Australia and will include a total of at least 40 subjects.
“We are pleased to have received approval from the Australian Bellberry Human Research Ethics Committee (HREC) for the Vitargus Phase II study, which follows approval from the Central Research Ethics Committee (CREC) of The National Research Council of Thailand,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We are aiming to conduct site initiation visits (SIVs) next month in both Thailand and Australia so that we can begin the study in early 2023.”
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