ABVC BioPharma Selects Additional Vitargus® Phase II Study Site

Rhea-AI Summary

ABVC BioPharma has confirmed a new clinical site in Australia for its Phase II study of Vitargus®, a biodegradable vitreous substitute for retina re-attachment surgery. Located at the Sydney Eye Hospital, this site joins others in Australia and Thailand. The hospital has a strong track record in ophthalmology trials, with the potential to enroll 10 subjects weekly. Dr. Howard Doong emphasized the significance of this site's participation, as the retinal surgery device market is projected to reach $3.7 billion by 2027.

Positive

• New clinical site at Sydney Eye Hospital enhances patient recruitment capabilities.
• Sydney Eye Hospital has over 10 years of experience in clinical trials.
• Potential enrollment rate of 10 subjects per week can expedite study progress.
• Positive market outlook for retinal surgery devices, expected to reach $3.7 billion by 2027.

Negative

• None.

New Australia Site Confirmed to Participate in the Study

FREMONT, CA, Sept. 09, 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 a new clinical site in Australia has been selected to participate in the Phase II clinical study of Vitargus®, the first bio-degradable vitreous substitute to facilitate retina re-attachment surgery. The new site, located at the Sydney Eye Hospital in Sydney, New South Wales, will join East Melbourne Eye Group in East Melbourne, Victoria, Australia and Ramathibodi Hospital and Srinagarind Hospital in Thailand, to participate in the study.

The Sydney Eye Hospital is a well-established site for clinical trials with over 10 years’ experience including 23 completed and 22 on-going ophthalmology studies.  The site has sufficient staff and resources to conduct the trial to a high standard with a potential enrollment rate of 10 subjects per week. 

“We are pleased to confirm that the Sydney Eye Hospital will join our Phase II clinical study. As a well-established ophthalmology clinical study site, the Sydney Eye Hospital will conduct the study at the highest quality standard and, as a result, increase the overall patient recruiting rate,” said Dr. Howard Doong, Chief Executive Officer of the Company. Dr. Doong further noted, “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.”

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
Stephanie Oshchepkov
Phone: +1 (203) 682-7175
Email: Stephanie.Oshchepkov@icrinc.com

FAQ

What is the significance of the new site confirmed for ABVC's Vitargus study?

The Sydney Eye Hospital's participation in the Phase II study is expected to increase patient recruitment rates, enhancing the trial's efficiency.

How many clinical sites are involved in the ABVC Vitargus study?

The study includes sites in Australia and Thailand, specifically the Sydney Eye Hospital, East Melbourne Eye Group, Ramathibodi Hospital, and Srinagarind Hospital.

What is the expected market size for retinal surgery devices?

The market for retinal surgery devices is projected to reach $3.7 billion by 2027, driven by an increasing geriatric population.