New Process Improves Quality and Lowers Cost
Fremont, CA, May 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 that Vitargus®, its gel-like substance that helps the eye maintain a round shape and keeps the retina in place during and after retinal re-attachment surgery, will be manufactured through a new aseptic process that enhances the stability, consistency and efficacy of the final product, while significantly reducing manufacturing time. This new manufacturing process eliminates the labor-intensive and time-consuming gamma ray sterilization of the Vitargus components by using a sterile fill-lyophilization-finish (FLF).
“We are pleased to have an innovative and experienced R&D team dedicated to developing new manufacturing technologies for Vitargus that improve quality and reduce manufacturing cost,” said Dr. Howard Doong, Chief Executive Officer of ABVC. “With this new process, we can easily transform Vitargus to a high-volume commercial product.”
Early clinical studies indicate that Vitargus has unique properties that eliminate the need for post-surgery patient face-down positioning, while significantly improving patient comfort and visual acuity during the surgical recovery period, as compared to current products available on the market. It is the first biodegradable vitreous substitute to eliminate the need for a second post-op surgery to remove surgical fluids. The upcoming Phase II study to be initiated in Australia and Thailand is expected to demonstrate the safety and effectiveness of Vitargus®, compared to the commonly used SF6 Gas OE. The new streamlined manufacturing process has been successfully scaled up under cGMP conditions to ensure enough Vitargus can be economically produced for both Phase II, as well as subsequent Phase III clinical studies involving more than 175 patients.
As reported in April 2021 by 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 (https://www.ihealthcareanalyst.com/technological-advancement-ophthalmic-surgery-retinal-surgery-devi….
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.
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.
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