YD Bio outlines 2026 clinical roadmap for eye treatments

YD Bio Limited (NASDAQ: YDES) announced completion of manufacturing development for its stem cell therapy platforms and outlined plans for clinical trials beginning in 2026. The biotechnology company said it has finished chemistry, manufacturing and controls development for its limbal stem cell platform and related exosome products.

The company filed Drug Master Files with the FDA for both limbal stem cells and LSC-derived exosomes. YD Bio plans to submit Investigational New Drug applications in 2026 for two eye treatment programs using its exosome platform, pending regulatory feedback and manufacturing readiness.

For dry eye disease treatment using LSC exosome eye drops, the company expects to establish a clinical-grade cell bank and submit an IND application to the FDA in 2026, with a Phase I trial planned for 2027. For age-related macular degeneration therapy, YD Bio plans to complete preclinical studies and submit an IND in 2026, targeting first-in-human trials in 2027.

The company is conducting a clinical study in Taiwan for LSC exosome eye drops at Ministry of Health and Welfare Shuang Ho Hospital, with subject enrollment expected to begin following institutional review board approval.

Through affiliate EG BioMed, YD Bio operates laboratory services across 46 U.S. states offering tests for early detection of pancreatic, breast, colorectal and gastrointestinal cancers. The company plans to seek registration in Maryland, Pennsylvania, Rhode Island and New Jersey in 2026.

YD Bio expects to complete patient enrollment for its OkaiDx pancreatic cancer detection program in 2026 and plans to submit an FDA Q-Submission to discuss potential Breakthrough Device eligibility. The company also outlined plans to evaluate up to three acquisitions in 2026 to enhance its capabilities, though timing and success remain uncertain.

The information is based on a company press release statement.

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