Thailand Sites Join Australian Sites Confirmed to Participate in the Study
Fremont, CA – 
(NewMediaWire) – January 05, 2022 – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced two clinical sites in Thailand have been selected to participate in the Phase II clinical study of Vitargus®, the first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery. The new sites, located at the Ramathibodi Hospital at Mahidol University and the Srinagarind Hospital at Khon Kaen University, will join two planned Australian sites already selected to participate in the study. The Company expects the Thailand Food and Drug Administration (“FDA”) and the Australian Therapeutic Goods Administration to approve the study sites and principal investigators in Q1 of 2022 with first patient enrollments beginning during Q2 of 2022.
“With the additional Thailand sites, we are pleased to be well along in our plan to have at least four countries included in the Vitargus Phase II study by the end of 2022, as we also continue our discussions with the United States FDA to hopefully include U.S. patients in the study later this year or in 2023,” said Dr. Howard Doong, Chief Executive Officer of the Company. “During the year, we intend to keep big pharma companies that have expressed an interest in distributing Vitargus apprised of the study data as it becomes available.”
Early clinical studies indicate that Vitargus® has unique properties that eliminate the need for post-surgery patient face-down positioning and significantly improves recovery period patient comfort and visual acuity compared to existing products. The objective of the Phase II study, “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE),” is to demonstrate the safety and efficacy of Vitargus® as compared to SF6 Gas OE, now commonly used for retina re-attachment. The incident of retinal detachment in Thailand is about 3% by the age of 851, compared to the incident of retinal detachment in Australia, which affects about 1% of the population2.
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.
1 Chokboonpiem J, Akrapipatkul, and Wongkumchang N; Visual field recovery after pars plana vitrectomy procedure for rhegmatogenous retinal detachment. EyeSEA 2017; 12(1): 50-56. Retrieved from https://he01.tci-thaijo.org/index.php/eyesea/index.
2 Retinal detachment. Chatswood Eye Specialists. Retrieved from https://www.chatswoodeye.com/retinal-detachment/.
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.
Forward-Looking Statements
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Lucy Peng
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Email: Lucy.Peng@icrinc.com