TearSolutions, Inc.

TearSolutions Receives FDA Orphan Drug and Fast Track Designations for Lacripep in Neurotrophic Keratitis, Initiates Phase 2 Trial

- TearSolutions received FDA Orphan Drug and Fast Track designations for Lacripep, a first-in-class synthetic peptide therapy for neurotrophic keratitis (NK), a rare degenerative corneal disease. - The company has initiated a multicenter, randomized, vehicle-controlled Phase 2 clinical trial (NCT07568730) enrolling approximately 54 patients with Stage 1 NK across three U.S. sites. - Lacripep is a synthetic 10-amino acid fragment of the human tear protein lacritin, designed to repair corneal epithelium and restore sensory nerve function via topical eye drop administration. - Prior Phase 1/2 data in primary Sjögren's Syndrome showed rapid improvement in corneal health and symptom reduction as early as two weeks.