Pipeline
Eye-Related Products
Overview
YD Biopharma’s Eye Health Product Line advances ocular innovation through a strategic partnership with 3D Global Biotech Inc., securing exclusive global distribution rights to FDA-registered ophthalmic solutions. The portfolio includes ExoLens contact lens cleared by the U.S. FDA as a Class II medical device (510(k) K213119), offering high comfort, safety, and visual clarity; and LensMate, a Class I sterile solution registered under the category of synthetic cell and tissue culture media and components. Together, these products exemplify YD Biopharma’s commitment to regulatory excellence and global market readiness in addressing the evolving needs of modern eye care.
Product
3D LensMate
ExoLens Contact Lenses
Product Classification & Regulatory Strategy
US FDA Registration &
Market Approval
European CE Mark
Japan PMDA
3D LensMate
Regulatory Status
In 2025, LensMate was successfully registered with the U.S. Food and Drug Administration (FDA) as a Class I Medical Device under the category “Synthetic Cell and Tissue Culture Media and Components”. This classification is applicable to sterile solutions intended for use in supporting biological environments and ex vivo tissue contact applications, and is exempt from premarket notification (510(k)) under FDA regulations.
Product Overview
LensMate is a biocompatible, sterile solution formulated to support tissue interface hydration and conditioning in research and biomedical device settings. Developed using defined synthetic components, it provides a stable and safe medium for non-implantable surface contact with biological specimens or external tissues during laboratory procedures.
While LensMate’s formulation is inspired by ocular applications, it is not classified or promoted as an eye drop or contact lens care solution, and is not intended for direct intraocular or long-term ocular surface use in humans without additional regulatory clearances.
Next Steps
Ongoing R&D aims to explore extended biomedical utility for LensMate, including its application as a hydration interface medium in regulated ophthalmic device protocols. YD Biopharma remains committed to advancing its regulatory profile through robust scientific validation, formulation refinement, and engagement with global health authorities.
3D ExoLens contact lens
Regulatory Status
In 2025, ExoLens, a soft disposable contact lens developed by 3D Global Biotech Inc., received U.S. FDA 510(k) clearance (K213119) as a Class II Medical Device under the classification Lenses, Soft Contact, Daily Wear (21 CFR 886.5925). The product is registered with the FDA under Product Codes LPL and MVN, confirming its regulatory compliance for ophthalmic use in the United States.
Product Overview
ExoLens is a soft contact lens designed for daily wear, developed to provide optimal comfort, corneal oxygenation, and long-lasting hydration throughout the day. Engineered with advanced biocompatible polymers, ExoLens offers high optical clarity and surface stability, making it suitable for routine visual correction and all-day ocular health support.
Its FDA Class II designation assures rigorous quality, safety, and performance testing, including biocompatibility, lens material characteristics, and sterility, in compliance with the U.S. FDA’s medical device regulations.
Next Steps
Ongoing development efforts aim to expand the ExoLens platform with innovations in lens material, blue-light filtering, and extended-wear variants. R&D initiatives are focused on integrating comfort-enhancing biomaterials and potentially combining with therapeutic agents or adjunctive lens care systems for future next-generation ophthalmic solutions.
