United States-based clinical-stage biotechnology company TearSolutions is dosing its first patients in a clinical trial of Lacripep, a potential first-in-class treatment for neurotrophic keratitis (NK).
The initiation of the Phase 2 clinical trial, which is expected to enrol approximately 54 participants, follows receipt of ‘Orphan Drug’ and ‘Fast Track’ designations from the US Food and Drug Administration.1
NK is a degenerative corneal disease marked by reduced or absent corneal sensitivity and impaired corneal healing. The condition can lead to persistent epithelial defects and vision loss.
Lacripep is a synthetic peptide derived from lacritin, a human tear protein.
… preclinical and early studies suggest the therapy has dual neurotrophic and prosecretory functions, with the aim of addressing underlying nerve damage, restoring basal tear secretion, and improving corneal epithelial health
According to TearSolutions, preclinical and early studies suggest the therapy has dual neurotrophic and prosecretory functions, with the aim of addressing underlying nerve damage, restoring basal tear secretion, and improving corneal epithelial health.
“Receiving both Orphan Drug and Fast Track designations from the FDA is a significant milestone that underscores the unmet medical needs that still exist in neurotrophic keratitis and the potential for Lacripep to transform how this disease is treated,” said TearSolutions CEO Anil Asrani.
“These designations validate our approach and afford us the opportunity to work closely with the FDA to accelerate our clinical development and bring this much-needed therapeutic option to patients sooner.”
Reference
- TearSolutions, TearSolutions receives FDA Orphan Drug and Fast Track designations for Lacripep in neurotrophic keratitis and Initiates Phase 2 clinical trial with first patients dosed, media release 2 June 2026, available at: tearsolutions.com/wp-content/uploads/2026/06/TearSolutions_PressRelease_June2026_FINAL-1.pdf [accessed July 2026].
