ABVC Biopharma, Inc. a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced the submission of its Vitrargus Phase II study to the Australian Bellberry Human Research Ethics Committee (HREC).
If the submission is received, HREC approval will lead to a Clinical Trial Notification (CTN) submission to the Australian Therapeutic Goods Administration (TGA) for review, which is the final regulatory step before study initiation.
Early clinical studies indicate that Vitargus has unique properties that result in eliminating the need for post-surgery patient face-down positioning, as well as significantly greater patient comfort and visual acuity during the surgical recovery period than currently available products. The objective of the Phase II study, titled “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 when compared to the commonly used SF6 Gas OE.
“The Phase II study is targeted to begin in August of 2022 in both Australia and Thailand and is expected to be completed by the end of 2023,” said Dr. Howard Doong, Chief Executive Officer of the ABVC. According to iHealthcareAnalyst, Inc., the global market for retinal surgery devices is expected to reach $3.7 billion by 2027, driven by a rising geriatric population worldwide.
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, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus®, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
(Source: Stockhouse, June 16th)