ABVC BioPharma Submitted Vitargus® Phase II Study Plan to Australia HREC
ABVC Biopharma (NASDAQ: ABVC) announced the submission of its Vitrargus Phase II study to the Australian Bellberry Human Research Ethics Committee (HREC). Approval from the HREC will enable a Clinical Trial Notification (CTN) submission to the Australian Therapeutic Goods Administration (TGA), marking a key step toward study initiation. The Phase II study aims to assess the safety and effectiveness of ABV-1701 Ocular Endotamponade compared to traditional SF6 Gas OE. The study is scheduled to commence in August 2022 and conclude by the end of 2023, targeting markets projected to reach $3.7 billion by 2027.
- Submission of Vitrargus Phase II study indicates progress in clinical developments.
- The study aims to demonstrate superior patient comfort compared to existing treatments.
- Potential entry into a growing retinal surgery market projected at $3.7 billion by 2027.
- No current revenue or profit generation from clinical trials.
- Risks surrounding regulatory approval and manufacturing capabilities.
FREMONT, CA, June 16, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC Biopharma, Inc. (NASDAQ: ABVC), 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 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
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.
Contact:
ICR, LLC
Lucy Peng
Phone: +1 646-677-1872
Email: Lucy.Peng@icrinc.com
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