ABVC BioPharma Provides Vitargus® Update
ABVC BioPharma, Inc. (NASDAQ: ABVC) announced an update on its vitreous substitute, Vitargus®, indicating early clinical success in eliminating the need for face-down positioning after surgery and offering better recovery comfort and visual acuity. The company selected its first clinical study site in Australia for a Phase II study expected to start in Q1 2022, and is preparing additional FDA-required data. ABVC is also in discussions with large pharmaceutical companies for potential partnerships. The retinal surgery device market is projected to reach $3.7 billion by 2027.
- Early clinical studies of Vitargus® show superior recovery comfort and visual acuity compared to current products.
- First clinical study site selected in Australia for Phase II study, with enrollments anticipated in Q1 2022.
- Active discussions with large pharmaceutical companies for distribution and manufacturing partnerships.
- FDA requested additional data which may delay the clinical trial progression.
- Uncertainty surrounding successful commercial manufacturing and regulatory approvals.
FREMONT, CA, Aug. 26, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today provided an update regarding recent developments in connection with Vitargus®, the world's first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery. 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 recovery period patient comfort and visual acuity than currently available products.
These developments include:
- ABVC has selected the first clinical study site and principal investigator for conducting a Phase II clinical study of Vitargus® in Australia. The objective of the study “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV1701 Ocular Endotamponade (OE)” is to demonstrate the safety and effectiveness of Vitargus® when compared to the commonly used SF6 Gas OE. Approval of the study by the Australian Therapeutic Goods Administration is expected in Q4 of 2021 with first patient enrollments beginning during Q1 of 2022.
- As previously disclosed, ABVC held a meeting with the US FDA on May 20, 2021, to review FDA comments regarding the results of the Vitargus® Phase I studies. The FDA requested additional data, primarily involving animal studies, which the company expects to provide early in 2022. ABVC was encouraged by the FDA discussion and strongly believes that the efficacy and safety of Vitargus® will be confirmed by the requested studies.
- The company continues to have active discussions with several large pharmaceutical companies interested in becoming distribution and/or manufacturing partners for Vitargus®.
“We are encouraged by the progress we continue to make towards the multi-nation, multi-site pivotal Phase III clinical studies, which are an important step to ultimately receiving PMA market approval for Vitargus®,” said Dr. Howard Doong, Chief Executive Officer of the Company. Dr. Doong further noted that “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
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. 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:
Andy An – Chief Financial Officer
765-610-8826
andyan@ambrivis.com
FAQ
What are the recent developments for ABVC BioPharma's Vitargus®?
When will the Phase II clinical study for Vitargus® start?
What is the market potential for retinal surgery devices according to ABVC?
What challenges does ABVC BioPharma face regarding FDA approval?
Is ABVC BioPharma seeking partnerships for Vitargus®?
