YD Bio Limited announced that it has received regulatory clearances for its first commercial eyecare products in the United States. The biotechnology company said its partner, 3D Global Biotech, obtained US Food and Drug Administration (FDA) 510(k) clearance for Exovisse Contact Lenses as a Class II medical device.

Additionally, YD Bio’s Exovisse Artificial Tears have been developed in compliance with FDA over-the-counter Final Monograph M018, allowing nationwide over-the-counter distribution without individual FDA premarket approval.

The company has also enrolled its limbal stem cells (LSC) and LSC-derived exosomes in the FDA Drug Master File, establishing quality and regulatory documentation to support future therapeutic development.