ABVC BioPharma Selects Additional Vitargus® Phase II Study Sites
ABVC BioPharma (NASDAQ: ABVC) has announced the addition of two clinical sites in Thailand for its Phase II study of Vitargus®, a biodegradable vitreous substitute for retina surgery. These sites will join two already confirmed in Australia, with enrollments expected to begin in Q2 2022 following regulatory approvals. The study aims to assess Vitargus®'s safety and efficacy compared to traditional options. With a projected market growth of retinal surgery devices reaching $3.7 billion by 2027, ABVC is positioning itself strongly in this sector.
- Expansion of clinical trial sites to Thailand enhances study's international scope.
- Potential market growth for Vitargus® in a projected $3.7 billion retinal surgery device market by 2027.
- Dependence on regulatory approvals from Thai and Australian authorities may delay the study.
- Challenges in securing U.S. patient inclusion may affect overall study scope.
Thailand Sites Join Australian Sites Confirmed to Participate in the Study
Fremont, CA, Jan. 05, 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 two clinical sites in Thailand have been selected to participate in the Phase II clinical study of Vitargus®, the first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery. The new sites, located at the Ramathibodi Hospital at Mahidol University and the Srinagarind Hospital at Khon Kaen University, will join two planned Australian sites already selected to participate in the study. The Company expects the Thailand Food and Drug Administration (“FDA”) and the Australian Therapeutic Goods Administration to approve the study sites and principal investigators in Q1 of 2022 with first patient enrollments beginning during Q2 of 2022.
“With the additional Thailand sites, we are pleased to be well along in our plan to have at least four countries included in the Vitargus Phase II study by the end of 2022, as we also continue our discussions with the United States FDA to hopefully include U.S. patients in the study later this year or in 2023,” said Dr. Howard Doong, Chief Executive Officer of the Company. “During the year, we intend to keep big pharma companies that have expressed an interest in distributing Vitargus apprised of the study data as it becomes available.”
Early clinical studies indicate that Vitargus® has unique properties that eliminate the need for post-surgery patient face-down positioning and significantly improves recovery period patient comfort and visual acuity compared to existing products. The objective of the Phase II study, “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE),” is to demonstrate the safety and efficacy of Vitargus® as compared to SF6 Gas OE, now commonly used for retina re-attachment. The incident of retinal detachment in Thailand is about
According to iHealthcareAnalyst, Inc., the global market for retinal surgery devices is expected to reach
1 Chokboonpiem J, Akrapipatkul, and Wongkumchang N; Visual field recovery after pars plana vitrectomy procedure for rhegmatogenous retinal detachment. EyeSEA 2017; 12(1): 50-56. Retrieved from https://he01.tci-thaijo.org/index.php/eyesea/index.
2 Retinal detachment. Chatswood Eye Specialists. Retrieved from https://www.chatswoodeye.com/retinal-detachment/.
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
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Lucy Peng
Phone: +1 646-677-1872
Email: Lucy.Peng@icrinc.com
FAQ
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