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Fremont, CA – 
The study notes, “The two most prevalent retinal degenerative diseases are – Age-related Macular Degeneration primarily affecting people age 60 and older and Retinitis Pigmentosa which is the most common inherited cause of blindness in people between the ages of 20 and 60 worldwide. Growing instances of retinal disorders in the geriatric population, eye injuries and rising prevalence of diabetic retinopathy are the key driving factors in the retinal surgery devices market.”
ABVC’s Vitargus® is a medical device intended to solve an important issue faced by surgeons following retinal re-attachment, namely patient comfort. Currently, in the U.S., there are approximately 250,000 vitrectomy surgeries each year, during which the surgeon uses small instruments to suction out the vitreous, a transparent, colorless, jelly-like, hydrophilic substance that fills the middle portion of the eye to better access the retina. This allows for a variety of repairs, including the removal of scar tissue, laser repair of retinal detachments and treatment of macular holes. After removing the vitreous substance, the surgeon typically injects a bubble of octafluoropropane or sulfur hexafluoride into the eye to help the retina stay in its proper position during the procedure. Many times, once the surgery is complete, the surgeon injects another solution such as silicone oil to hold the retina in place during the healing process. All of these products have disadvantages that often lead to medical complications and, in the case of silicone oil, require a second surgery to remove the oil.
Vitargus®, a gel-like substance that helps the eye maintain a round shape, has shown to keep the retina in place during and after retinal re-attachment surgery. The product is a combination of oxidized hyaluronic acid (oxi-HA), adipic acid dihydrazide (ADH), and phosphate-buffered saline (PBS), transforming from liquid to gel after injection. It 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. It is also a biodegradable vitreous substitute that eliminates the need for a second post-op surgery to remove surgical fluids such as silicone oil. Vitargus permits a patient to have unrestricted post-surgery movement or activity, and, as a result of these and other benefits, the Company believes that it will have a significant global impact on retinal re-attachment surgery.
Phase II clinical studies of Vitargus initiated in Australia and Thailand are expected to continue to demonstrate the safety and effectiveness of Vitargus®, compared to the most commonly used substance, SF6 Gas OE. Additional Phase II studies are expected to be initiated in Taiwan and India later in 2022 and in the United States in 2023. Global out-licensing agreements in Australia, Thailand, Taiwan, United States, Japan, mainland China, and India are expected before the end of 2024.
“The Bosson report further instills confidence in our investment in Vitargus and bodes well for our long-term development,” said Dr. Howard Doong, Chief Executive Officer of ABVC. “Further, as a result of early clinical studies demonstrating that Vitargus may be the key to significantly enhancing patient post-surgical comfort, we have received indications of potential interest in collaborating on Vitargus from several regional and global pharmaceutical companies.”
To prepare for Vitargus market entry, the Company has designed a new manufacturing 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 Vitargus components by using a sterile fill-lyophilization-finish (FLF), which has been successfully scaled up under cGMP conditions to ensure enough Vitargus can be economically produced for both Phase II and subsequent Phase III clinical studies involving more than 300 patients. ABVC anticipates an initial pricing of approximately $2,500 per year per surgical procedure in the U.S., which represents a premium to Alcon’s Perfluoron (SOC liquid vitreous substitute) of $2,040. Based on this pricing, if ABVC captures a modest mid-single digit percentage market share, management believes this could represent significant revenues on an annualized basis beginning in 2024.
References
Bosson Research (2022). Global Retinal Surgery Devices Market Research Report 2022 (Status and Outlook). (Report No. 5619987). https://www.researchandmarkets.com/reports/5619987/global-retinal-surgery-devices-market-research
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
ICR, LLC
Lucy Peng
Phone: +1 646-677-1872
Email: Lucy.Peng@icrinc.com
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