YD Bio secures FDA agreement to provide early guidance on dry eye drug candidate
YDES•YD Bio secured FDA agreement to provide early regulatory guidance on its investigational dry eye biologic eye drop. Written feedback is expected by January 4, 2027, on manufacturing controls and proposed animal testing.
1. FDA feedback planned
YD Bio secured FDA agreement to provide early regulatory guidance on YDB-LMSCEV-001, an investigational biologic eye drop for moderate-to-severe dry eye disease. Written feedback is expected by January 4, 2027, covering manufacturing controls and proposed early animal testing.
2. Studies and next steps
Initial laboratory and mouse studies are complete, and YD Bio submitted a proposed follow-up animal study for FDA review. The feedback will guide manufacturing improvements and confirmatory animal studies ahead of a pre-IND meeting, a regulatory step before human trials.
