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Taiwan-based biotechnology company YD Bio (YDES) said on Monday that it has reached a set of milestones that together mark its commercial entry into U.S. eye care.
Following the announcement, shares of the firm traded 7% higher at the time of writing.
The Taiwan-based company said that Exovisse Contact Lenses have obtained U.S. Food and Drug Administration clearance through its partner, 3D Global Biotech, confirming that the lenses are substantially equivalent to an already marketed device and can be sold in the U.S.
The company also said that its Exovisse Artificial Tears have been developed in compliance with FDA mandates permitting nationwide over‑the‑counter distribution for eye hydration and dry eye comfort without individual FDA premarket approval.
YD Bio now plans to conduct a small clinical trial in Taiwan to evaluate dry eye disease in collaboration with 3D Global Biotech and Taiwan-based contract research organization YC Biotech.
The company is also advancing LSC Exosome Therapeutics through its collaboration with 3D Global Biotech for retinal and macular disorders. LSC exosome therapeutics refers to the use of exosomes derived from limbal stem cells (LSCs) for therapeutic purposes, particularly for conditions affecting the eye, like dry eye syndrome.
The company said that it has enrolled its limbal stem cells and limbal stem cell exosomes in the FDA Drug Master File, establishing documentation to support future therapeutic development.
On Stocktwits, retail sentiment around YDES stayed within the ‘neutral’ territory while message volume remained at ‘extremely low’ levels.
YDES stock is down by 20% this year and by about 22% over the past 12 months.
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