GlobeNewswire·Nov 12, 2026, 4:30 PM ET

YD Bio Announces FDA Grant of INTERACT Meeting Request for YDB-LMSCEV-001, an Investigational Extracellular Vesicle Candidate for Dry Eye Disease

YD Bio Limited received FDA approval for an INTERACT meeting regarding its investigational eye drop YDB-LMSCEV-001 for moderate-to-severe dry eye disease.
The FDA's Center for Biologics Evaluation and Research (CBER) agreed to provide written regulatory feedback via a Written Response Only format.
Written guidance from the FDA is expected by January 4, 2027.
YD Bio submitted nine specific questions to the FDA, including seven regarding chemistry, manufacturing, controls, cell bank qualification, donor eligibility, safety, consistency, and two regarding early animal testing design.
The feedback aims to help finalize manufacturing processes & preclinical plans before a formal pre-Investigational New Drug meeting.
The product utilizes extracellular vesicles derived from allogeneic human limbal mesenchymal stem cells.
YD Bio has established laboratory-scale donor master cell banks & completed initial lab studies in mice for dry eye disease.
A proposed follow-up proof-of-concept animal study was submitted to the FDA for review.
YC Biotech consulted on the FDA submission while YD Bio USA Inc. acted as the U.S. agent & formal liaison.
YDB-LMSCEV-001 remains at the preclinical stage with no established safety or efficacy & has not been approved by any regulatory authority.

Company: YD Bio Limited
Keywords: Nasdaq:YDES, YD Bio Limited, YD Bio Limited, Nasdaq: YDES, YDB-LMSCEV-001, Dry Eye Disease, INTERACT Meeting, FDA, DNA methylation-based, cancer detection