Revolutionary Patented Technology Poised to Address Unmet Medical Needs in a Transformative $4.3 Billion Market Opportunity

FREMONT, CA - January 7, 2025 (NEWMEDIAWIRE) -  ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company focused on innovative treatments in ophthalmology, CNS (central nervous system), and oncology/hematology, today announced updates regarding Vitargus®, a first-of-its-kind biodegradable vitreous substitute designed to improve outcomes for patients undergoing vitrectomy procedures. ABVC holds U.S. patents for Vitargus®, as well as patents from many other countries; the patents are valid until 2030-31. ABVC BioPharma, BioFirst Corporation (ABVC subsidiary), and ForSeeCon’s strategic licensing agreements are expected to advance Vitargus® toward global commercialization. Under the terms of the agreements, ABVC and BioFirst have received $116,000 in milestone payments to date and have the potential to receive total licensing fees valued at up to $187 million, including other milestone payments and royalties, based on the party’s internal valuation of ForSeeCon’s private stock. ForSeeCon, committed to expanding its presence in the European market, is progressing diligently toward market entry, ensuring compliance with regional regulatory frameworks. The partnership extends beyond Vitargus®, with the parties collaborating on innovative ophthalmology projects to enrich ForSeeCon's pipeline. These joint efforts are designed to increase revenue and accelerate the development of transformative solutions for retinal care, reinforcing both companies' goals to become leaders in the field.

About Vitargus®

Vitargus® is the world's first one-of-a-kind biodegradable hydrogel vitreous substitute with a unique combination of properties that our internal clinical studies have shown to enhance retinal reattachment surgery. Derived from hyaluronic acid, a natural substance in the human body, we believe that Vitargus® provides superior visual and structural support, making it a game-changer in vitreoretinal surgery. ABVC BioPharma has a strategic licensing agreement with ForSeeCon Eye Corporation (FEYE), a company known for its dedication to advancing ophthalmology. FEYE’s interest in innovative solutions for retinal diseases aligns with ABVC BioPharma’s commitment to addressing unmet needs in the field. The collaboration focuses on Vitargus® and has a potential deal value of $187 million, including milestone payments and future royalties. FEYE’s expertise in the ophthalmology market and its robust network in Asia and Europe is critical in accelerating the commercialization and adoption of Vitargus® as a revolutionary vitreous substitute for retinal reattachment surgeries.

Why Vitargus® Stands Out

Compared to traditional vitreous substitutes like silicone oil and C3F8 gas, based on our internal clinical studies to date, Vitargus® delivers the following advantages:

1. Biodegradability and Long-term Use[1]:

• Vitargus® is biodegradable and eliminates the need for secondary surgery to remove the substitute, reducing patient risk and healthcare costs.
• C3F8 and Silicone Oil: These require additional surgeries to remove or are absorbed over time, but they pose risks of complications, such as emulsification (silicone oil).

2. Patient Recovery and Comfort[2]:

• Vitargus® does not require patients to maintain a face-down position after surgery, which is believed to improve recovery comfort.
• C3F8 Gas: Requires strict face-down positioning for several days to weeks, impacting patient compliance and comfort.
• Silicone Oil: Eliminates face-down positioning but often leads to elevated intraocular pressure and cataract formation.

3. Visual Outcomes[3]:

• Vitargus®: Provides superior optical clarity and refractive properties, allowing for immediate post-operative vision improvement.
• C3F8 Gas and Silicone Oil: Limit immediate vision recovery due to bubble opacity or oil-related complications.

4. Market Challenges and Failures[4]:

• Vitargus®: Addresses major failure points such as retinal re-detachment and long-term complications with innovative hydrogel properties.
• C3F8 and Silicone Oil: Report failure rates as high as 15% in certain conditions due to retinal re-detachment or emulsification (PubMed, 2015).

5. Economic and Healthcare Impact[5]:

• Vitargus®: Potentially reduces overall healthcare costs by eliminating the need for follow-up surgeries.
• C3F8 and Silicone Oil: Increase healthcare costs due to secondary procedures and management of complications.

This comparative analysis emphasizes Vitargus® as a revolutionary product designed to overcome the limitations of traditional vitreous substitutes, improving both patient outcomes and economic efficiency.

Addressing an Unmet Need

Traditional substitutes like air, gas, or silicone oil present challenges, including retinal re-detachment, emulsification, and long-term complications. Approximately 15% of retinal reattachment surgeries fail when silicone oil is used[6]​. We believe that Vitargus® offers a safer and more effective alternative. Internal clinical trials have demonstrated significant improvements in visual acuity and reduced need for follow-up surgeries​.

Market Opportunity

The vitreous substitute market is valued at over $500 million annually; approximately 225,000 vitrectomy procedures are performed in the U.S. each year, and the demand is increasing due to conditions like diabetic retinopathy and macular degeneration[7]. Vitargus® is poised to meet this demand, addressing gaps in patient care​. The market should anticipate significant developments as Vitargus® takes center stage at upcoming ophthalmology and healthcare conferences. These platforms will showcase the latest clinical data, emphasizing the product’s groundbreaking potential to address long-standing challenges in vitreoretinal surgery. With its unique biodegradable properties, immediate vision recovery, and elimination of face-down positioning post-surgery, which have been shown in our first in-human studies, Vitargus® has already received positive feedback and garnered attention from leading industry experts.

Clinical Validation

Phase I studies of Vitargus® demonstrated safety and efficacy, with no adverse effects on ocular tissues and significant improvements in visual acuity. Thus far, the ongoing Phase II study further confirms its potential to redefine the standard of care in vitreoretinal surgeries​.

Future Outlook

ABVC BioPharma is advancing Vitargus® toward regulatory approvals in Asia and Europe, with plans to enter the U.S. market. We believe that with its innovative properties, it is a superior choice for retinal reattachment and other vitreoretinal conditions​.

Global Development Strategy

ABVC BioPharma is committed to bringing Vitargus® to markets worldwide. The company has strategic plans to introduce the product across multiple regions, including North America, Europe, and Asia-Pacific. The company actively engages with regulatory authorities to secure approvals and expand access to this innovative solution. Management believes the Company's product pipeline has excellent market potential. According to iHealthcare Analyst, Inc., the global market for retinal surgery devices is expected to reach $4.3 billion by 2029, at a CAGR of 7.7%, driven partly by the rising geriatric population worldwide[8].

Uttam Patil, Ph.D., Chief Executive Officer of ABVC., shared his thoughts on the transformative potential of Vitargus®:

"Vitargus® represents a significant leap forward in vitreoretinal surgery. At ABVC, we are committed to addressing the unmet needs of patients and advancing healthcare innovation. Vitargus® not only enhances surgical outcomes and dramatically improves the quality of life for patients recovering from vitrectomy procedures, its unique biodegradable and optical properties make it a game-changer in the field of ophthalmology. We are confident that Vitargus® will set a new standard of care and reinforce ABVC’s mission to deliver life-changing medical solutions to patients worldwide."

Dr. Patil further emphasized ABVC’s strategic focus: "As we continue to bring Vitargus® closer to market, we remain dedicated to our vision of delivering cutting-edge solutions that improve outcomes, reduce complications, and provide tangible value to patients and healthcare providers globally."

For more information about ABVC and its subsidiaries, stay updated on the latest updates or visit https://abvcpharma.com. ABVC urges its shareholders to sign up on the Company's website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

About ABVC BioPharma & Its Industry

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, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company's network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.

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. None of the outcomes expressed herein are guaranteed. 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.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Contact:

Dr. Uttam Patil
Email: uttam@ambrivis.com

[1] https://retinalphysician.com/issues/2007/janfeb/the-status-of-vitreous-substitutes/?utm_source=chatgpt.com

[2] https://pubmed.ncbi.nlm.nih.gov/27792212/

[3] https://www.globenewswire.com/news-release/2020/09/09/2090984/0/en/American-BriVision-Issues-Clinical-Study-Report-for-Vitargus-First-in-Human-Phase-I-Clinical-Trial.html?utm_source=chatgpt.com

[4] https://onlinelibrary.wiley.com/doi/epdf/10.1002/mabi.202100066?utm_source=chatgpt.com

[5] https://www.mdpi.com/1422-0067/24/4/3342

[6] https://bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03618-z?utm_source=chatgpt.com

[7] https://my.clevelandclinic.org/health/treatments/24402-vitrectomy?utm_source=chatgpt.com

[8] https://www.ihealthcareanalyst.com/technological-advancement-ophthalmic-surgery-retinal-surgery-devices-market/