YD Bio Limited Announces U.S. Ophthalmology Market Entry, Advances Across Diagnostics and LSC Exosome Therapeutics
Rhea-AI Summary
YD Bio (Nasdaq: YDES) announced U.S. ophthalmology regulatory and clinical milestones on Nov 24, 2025 that establish its first commercial entry into U.S. eye care and advance limbal stem cell (LSC) exosome therapeutics.
Key achievements: Exovisse Contact Lenses received FDA 510(k) clearance as a Class II device; Exovisse Artificial Tears were developed in compliance with the FDA OTC Final Monograph M018 for nationwide OTC distribution; and YD Bio enrolled its LSC and LSC-derived exosomes in an FDA Drug Master File to support future therapeutics.
Positive
- FDA 510(k) clearance for Exovisse Contact Lenses enabling U.S. marketing
- Exovisse Artificial Tears meet FDA OTC Final Monograph M018 requirements for nationwide sale
- Enrollment of LSC and LSC-derived exosomes in an FDA Drug Master File to support therapeutic development
- Planned small dry eye clinical trial in Taiwan with a contract research organization
Negative
- Development and commercial outcomes may be delayed by regulatory feedback, clinical validation, or partner execution
- Commercial success depends on customer acceptance and competitive dynamics in U.S. eye‑care markets
News Market Reaction
On the day this news was published, YDES gained 4.50%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.9% during that session. Argus tracked a trough of -11.7% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $30M to the company's valuation, bringing the market cap to $694M at that time.
Data tracked by StockTitan Argus on the day of publication.
Taipei, Taiwan, Nov. 24, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that the Company has reached a set of regulatory and clinical milestones that together mark its first commercial entry into U.S. eye care and limbal stem cells (“LSC”) exosome‑based therapeutics. Through its partner 3D Global Biotech Inc. (“3D Global Biotech”), Exovisse Contact Lenses have obtained FDA 510(k) clearance as a Class II medical device, enabling legal marketing in the United States. In parallel, its Exovisse Artificial Tears have been developed in compliance with the FDA OTC Final Monograph M018, permitting nationwide over‑the‑counter distribution for eye hydration and dry eye comfort without individual FDA premarket approval, and its LSC and LSC-derived exosomes has been enrolled in the FDA Drug Master File.
In plain terms, 510(k) clearance confirms the lenses are substantially equivalent to an already marketed device and can be sold in the U.S., while OTC monograph compliance confirms the artificial tears meet established safety and labeling requirements and can be marketed without case‑by‑case approval. For consumers, that means easier access to trusted solutions for comfort and clearer vision, which establishes a commercial foundation for YD Bio in ophthalmology that complements ongoing clinical development.
YD Bio and 3D Global Biotech are also planning a small clinical trial in Taiwan to evaluate dry eye disease, working with YC Biotech, a Taiwan‑based contract research organization. The Company is simultaneously advancing LSC Exosome Therapeutics through active collaboration with 3D Global Biotech, pursuing limbal stem cell–derived exosome applications via injection and eye drops for retinal and macular disorders. YD Bio has enrolled its limbal stem cells and limbal stem cell exosomes in the FDA Drug Master File, establishing quality and regulatory documentation to support future therapeutic development.
“Together, these achievements demonstrate YD Bio’s transition from laboratory innovation to patient‑ready products, while building a pipeline aimed at novel therapies for serious eye conditions,” Dr. Ethan Shen, Chairman and CEO of the Company, commented. “YD Bio is starting to make YD Bio’s everyday eye care products available in the U.S., which signals a pragmatic path from development to revenue within a large, needs‑based category.”
Development timelines and commercial outcomes may be affected by factors including technology evolution, clinical validation, regulatory feedback, partner execution, customer acceptance, competitive dynamics, and macroeconomic conditions. YD Bio will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments.
About YD Bio Limited
YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and limbal stem cell and exosome therapies with the potential to transform the treatment of diseases with high unmet medical need. The Company is committed to improving patient outcomes through scientific innovation and precision medicine. In addition to its R&D efforts, YD Bio Limited is a recognized supplier of clinical trial drugs and has expanded into the development and distribution of post-market auxiliary products. For more information, please visit the Company’s website: ir.ydesgroup.com
Forward-Looking Statements
Certain statements in this announcement are forward-looking statements, including, but not limited to, YD Bio’s business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on YD Bio’s current expectations and projections about future events that YD Bio believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. YD Bio undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although YD Bio believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and YD Bio cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in YD Bio’s registration statement and other filings with the U.S. Securities and Exchange Commission.
For investor and media inquiries, please contact:
YD Bio Limited
Investor Relations
Email: investor@ydesgroup.com
WFS Investor Relations Inc.
Email: services@wealthfsllc.com
Phone: +1 628 283 9214
FAQ
What does the FDA 510(k) clearance for Exovisse Contact Lenses mean for YD Bio (YDES)?
Are Exovisse Artificial Tears allowed to be sold over the counter in the U.S. for YD Bio (YDES)?
What is the significance of enrolling limbal stem cells and exosomes in an FDA Drug Master File for YD Bio (YDES)?
When and where will YD Bio (YDES) run the planned dry eye clinical trial?
How could YD Bio's (YDES) U.S. ophthalmology milestones affect near-term revenue?
