ABVC BioPharma Provides Vitargus® Update on Phase II Site Initiation Visit Conducted at Srinagarind Hospital in Thailand

Rhea-AI Summary

ABVC BioPharma (NASDAQ: ABVC) announced the successful Phase II Site Initiation Visit for Vitargus® at Srinagarind Hospital, Thailand, on March 9-10, 2023. The study aims to evaluate the safety and effectiveness of ABV-1701 Ocular Endotamponade in retinal detachment patients, enrolling at least 40 participants across four sites in Australia and Thailand. Vitargus® is a biodegradable vitreous substitute, improving patient comfort and visual recovery compared to existing methods. The global retinal surgery device market is projected to reach $3.7 billion by 2027, fueled by a growing elderly population. The company plans to advance its product through Phase III clinical trials.

Positive

• Successful completion of Vitargus® Phase II Site Initiation Visit.
• Initiation of patient screening and enrollment across four sites.
• Vitargus® is expected to significantly improve patient recovery experience.

Negative

• None.

FREMONT, Calif., March 20, 2023 /PRNewswire/ -- 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 Srinagarind Hospital, Khon Kaen University (TH002) was successfully conducted on March 9-10, 2023. The SIV was an organized meeting to discuss Phase II study protocol with the principal investigator and begin training clinical personnel.

ABVC BioPharma Provides Vitargus® Update on Phase II Site Initiation Visit Conducted at Srinagarind Hospital in Thailand

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 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 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 at Srinagarind Hospital, Khon Kaen University (TH002), and are ready for patient screening and enrollment," said Dr. Howard Doong, Chief Executive Officer of the Company. "The SIV's at Ramathibodi Hospital, Mahidol University (TH001) in Thailand, Sydney Eye Hospital (AU001), and East Melbourne Eye Group (AU002) in Australia is 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.

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.

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SOURCE ABVC Biopharma, Inc.

FAQ

What is the recent update on ABVC BioPharma's Vitargus®?

ABVC BioPharma successfully completed the Phase II Site Initiation Visit for Vitargus® on March 9-10, 2023, at Srinagarind Hospital, Thailand.

When was the Phase II Site Initiation Visit for Vitargus® conducted?

The Phase II Site Initiation Visit for Vitargus® was conducted on March 9-10, 2023.

What is the focus of the Vitargus® Phase II study?

The study focuses on evaluating the safety and effectiveness of ABV-1701 in patients with retinal detachment.

How many patients will be enrolled in the Vitargus® Phase II study?

The study aims to enroll at least 40 patients across four sites in Australia and Thailand.

What market potential does the retinal surgery device sector hold?

The global market for retinal surgery devices is estimated to reach $3.7 billion by 2027.