YD Bio Limited Announces U.S. Ophthalmology Market Entry, Advances Across Diagnostics and LSC Exosome Therapeutics
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.
YD Bio (Nasdaq: YDES) ha annunciato traguardi normativi e clinici negli Stati Uniti nel campo oculistico il 24 novembre 2025 che segnano il primo ingresso commerciale nelle cure oculari statunitensi e avanzano le terapie a base di esosomi di cellule staminali limbali (LSC).
Raggiungimenti chiave: Exovisse Contact Lenses hanno ottenuto la convalida FDA 510(k) come dispositivo di Classe II; Exovisse Artificial Tears sono state sviluppate in conformità con la Monografia OTC finale M018 della FDA per la distribuzione OTC su tutto il territorio; e YD Bio ha iscritto i suoi LSC e gli esosomi derivati da LSC in un Drug Master File della FDA per supportare futuri terapie.
YD Bio (Nasdaq: YDES) anunció hitos regulatorios y clínicos en Estados Unidos en el campo de la oftalmología el 24 de noviembre de 2025 que establecen su primera entrada comercial en el cuidado ocular de EE. UU. y avanzan las terapias de exosomas derivados de células madre limbares (LSC).
Logros clave: Exovisse Contact Lenses obtuvo la autorización 510(k) de la FDA como dispositivo de Clase II; Exovisse Artificial Tears se desarrollaron cumpliendo la Monografía Final OTC M018 de la FDA para distribución OTC a nivel nacional; y YD Bio inscribió sus LSC y exosomas derivados de LSC en un Drug Master File de la FDA para apoyar terapias futuras.
YD Bio (나스닥: YDES)가 미국 안과 분야에서 2025년 11월 24일에 최초의 미국 내 상용 진입을 확립하고 각막 줄기세포(LSC)에서 유래한 엑소좀 치료제를 발전시키는 미국 규제 및 임상 이정표를 발표했습니다.
주요 성과: Exovisse Contact Lenses가 Class II 기기로서 FDA 510(k) 승인을 받았고; Exovisse Artificial Tears는 FDA OTC 최종 모노그래프 M018를 준수하여 전국적 OTC 유통을 위한 개발이 완료되었으며; YD Bio는 향후 치료제를 지원하기 위해 LSC 및 LSC 유래 엑소좀을 FDA Drug Master File에 등록했습니다.
YD Bio (Nasdaq: YDES) a annoncé des jalons réglementaires et cliniques aux États-Unis dans le domaine ophtalmologique le 24 novembre 2025 qui établissent sa première entrée commerciale dans les soins oculaires américains et font progresser les thérapies par exosomes dérivés de cellules souches limbales (LSC).
Réalisations clés : Exovisse Contact Lenses ont reçu l'autorisation 510(k) de la FDA en tant que dispositif de Classe II ; Exovisse Artificial Tears ont été développées conformément à la Monographie OTC finale M018 de la FDA pour une distribution OTC à l'échelle nationale ; et YD Bio a enregistré ses LSC et exosomes dérivés de LSC dans un Drug Master File de la FDA pour soutenir les thérapies futures.
YD Bio (Nasdaq: YDES) kündigte am 24. November 2025 in den USA regulatorische und klinische Meilensteine im Bereich der Ophthalmologie an, die seinen ersten kommerziellen Einstieg in die US-Augenheilkunde festlegen und Therapien mit Exosomen aus limbalen Stammzellen (LSC) voranbringen.
Wichtige Errungenschaften: Exovisse Contact Lenses erhielten die FDA 510(k)-Freigabe als Klasse-II-Gerät; Exovisse Artificial Tears wurden in Übereinstimmung mit der FDA OTC Final Monograph M018 für den landesweiten OTC-Vertrieb entwickelt; und YD Bio hat seine LSC und LSC-abgeleiteten Exosomen in eine FDA Drug Master File aufgenommen, um zukünftige Therapeutika zu unterstützen.
YD Bio (بورصة ناسداك: YDES) أعلنت عن معالم تنظيمية وعيادية في الولايات المتحدة في مجال العناية بالعين بتاريخ 24 نوفمبر 2025 والتي تؤسس لدخولها التجاري الأول في رعاية العين الأمريكية وتدفع بعلاجين باستخدام إسوسومات من الخلايا الجذعية الحدَوبية (LSC).
الإنجازات الرئيسية: Exovisse Contact Lenses حصلت على موافقة FDA 510(k) كجهاز من الفئة الثانية؛ وExovisse Artificial Tears تم تطويرها بما يتوافق مع مونوجراف OTC النهائي M018 من FDA لتوزيع OTC على مستوى البلاد؛ وقامت شركة YD Bio بتسجيل LSC و إسوسوماتها المستمدة من LSCS في ملف Drug Master File لدى FDA لدعم العلاجات المستقبلية.
- 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
- 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
Insights
YD Bio achieved U.S. market entry milestones enabling immediate OTC and Class II device sales while preserving a regulatory pathway for future therapeutics.
YD Bio and partner 3D Global Biotech secured FDA 510(k) clearance for Exovisse Contact Lenses and complied with the FDA OTC Final Monograph M018 for Exovisse Artificial Tears, enabling legal U.S. marketing and nationwide over‑the‑counter distribution as of
The business mechanism is straightforward: device clearance and OTC monograph compliance permit immediate commercial activity and revenue generation for consumer eye‑care products, while the Drug Master File preserves a regulatory record to support investigational or marketing applications for biologic exosome therapies. Risks and dependencies include partner execution on U.S. commercialization, the scope of the 510(k) indications versus intended uses, the requirement for clinical validation for therapeutic claims, and regulatory feedback for any future drug or biologic submissions.
Watch for three concrete items over the near term: filings and labeling consistent with OTC monograph rules and 510(k) scope, initiation and interim results of the planned small dry eye clinical trial in Taiwan, and any FDA communications referencing the Drug Master File content; expect updates within the next 6–18 months as commercialization and early clinical work progress.
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
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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?
