ABVC BioPharma Announces Vitargus Phase II Clinical Study Investigator Meeting

FREMONT, CA - (NewMediaWire) - April 26, 2022 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the principal investigators of the Phase II clinical study of Vitargus® will hold a virtual meeting on April 27, 2022. The meeting will be attended by all principal investigators currently selected from the Australian and Thailand sites to help coordinate the study, entitled “A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE).” 

“We are proceeding steadily according to our Vitargus® development plan,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “The investigator meeting will facilitate a mutual understanding of the study’s goals and set procedures to share experiences among the Principal Investigators. The Australian and Thai sites are expected to enroll approximately 40 patients in the study, which is a good starting point for our goal to enroll at least 175 patients in multiple countries by the end of 2023.”

Early clinical studies indicate that Vitargus® has unique properties that eliminate the need for post-surgery patient face-down positioning, while significantly improving patient comfort and visual acuity during the surgical recovery period, as compared to current products available on the market. It is the first biodegradable vitreous substitute to eliminate the need for a second post-op surgery to remove surgical fluids. The objective of the Phase II study is to demonstrate the safety and effectiveness of Vitargus®, compared to the commonly used SF6 Gas OE.

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

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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

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. 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.

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