Fremont, CA - (NewMediaWire) - April 06, 2023 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that Vitargus® Phase II Site Initiation Visit (SIV) at Ramathibodi Hospital, Faculty of Medicine, Mahidol University (TH001) in Thailand was successfully conducted on March 22, 2023. The SIV was an organized meeting to discuss the Phase II study protocol with the principal investigator, Duangnate Rojanaporn, M.D. and begin training clinical personnel.
Vitargus® Phase II study with the protocol “A Prospective Multi-Site Open-Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)” is to demonstrate safety and effectiveness of Vitargus® in patients with Retinal Detachment compared to the commonly used Sulphur Hexafluoride (SF6) Gas OE. The Phase II study screening and enrollment has been initiated and will aim to enroll at least 40 patients across all four sites in Australia and Thailand. More information on the clinical trial (NCT05414747) can be found here.
Early clinical studies done by the Company indicate Vitargus® has unique properties that could eliminate the need for patients to remain in a face-down position post-surgery, while significantly improving patient comfort and visual acuity during surgical recovery compared to current products available on the market. Vitargus® is believed to be the first biodegradable vitreous substitute to eliminate the need for an additional surgery to remove surgical fluids.
“We are pleased to see the SIV completed successfully with Dr. Duangnate Rojanaporn, M.D. and her clinical team at Ramathibodi Hospital, Faculty of Medicine, Mahidol University (TH001), and are ready for patient screening and enrollment,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We are currently enrolling patients at Srinagarind Hospital, Khon Kaen University (TH002), which completed its SIV on March 10, 2023. The SIVs at Sydney Eye Hospital (AU001) and East Melbourne Eye Group (AU002) in Australia are expected to be conducted shortly.”
According to iHealthcareAnalyst, Inc., the global market for retinal surgery devices is expected to reach $3.7 billion by 2027, driven by the 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, 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.
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