New Process Improves Quality and Lowers Cost
Fremont, CA - (NewMediaWire) - May 05, 2022 - 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.
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