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
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
Tom Masterson
Email: tmasterson@allelecomms.com