ABVC BioPharma Receives Australian TGA Approval to Initiate Phase II Study of Vitargus®
ABVC BioPharma, Inc. (NASDAQ: ABVC) announced the approval of its Phase II study for the Vitargus® medical device by the Australian Therapeutic Goods Administration (TGA) on February 9, 2023. Vitargus is the first biodegradable vitreous substitute designed to enhance patient comfort during retina reattachment surgery. The study aims to compare the safety and effectiveness of Vitargus against the commonly used SF6 Gas. It will enroll at least 40 subjects across two sites in Australia and includes hospitals in Thailand. The retinal surgery devices market is projected to reach $3.7 billion by 2027, driven by a growing geriatric population.
- Approval of Phase II study for Vitargus from Australian TGA.
- First biodegradable vitreous substitute potentially enhancing patient comfort.
- Study aims to demonstrate Vitargus safety and effectiveness in retina surgeries.
- None.
FREMONT, CA, Feb. 21, 2023 (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 that approval to initiate the Phase II study of its Vitargus® medical device, in Australia, was received from the Australian Therapeutic Goods Administration (TGA) on February 9, 2023. Vitargus is the first biodegradable vitreous substitute to facilitate retina reattachment surgery.
“We are pleased to receive Vitargus Phase II study approval from Australian TGA to enable initiating the study at two prestigious Australian sites,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We expect the study to further demonstrate that Vitargus has properties that eliminate the need for post-surgery patient face-down positioning and can provide greater patient comfort and visual acuity during the surgical recovery period.” Dr. Doong further noted that "Since Australia is recognized throughout the world for its advanced biotech research, receiving TGA approval will certainly encourage other countries to permit clinical studies of Vitargus as well.”
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 effectiveness of Vitargus for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. Two Australian sites, Sydney Eye Hospital directed by Professor/Dr. Matthew Simunovic in New South Wales and East Melbourne Eye Group & East Melbourne Retina directed by Dr. Elvis Ojaimi in East Melbourne, will participate in the study. Along with Thai FDA approved Ramathibodi Hospital and Srinagarind Hospital in Thailand, the study will enroll a total of at least 40 subjects.
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:
Leeds Chow, CFO
Email: leedschow@ambrivis.com
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