The quality of human tear film is critical for corneal epithelial and neuronal cell survival. Several tear proteins are deficient in different forms of Dry Eye, the most common eye disease. One, called Lacritin, is deficient in all forms of Dry Eye and when reintroduced, health is restored. TearSolutions has developed ‘Lacripep’, which is derived from Lacritin protein as a first-in-class topical therapy that preserves all of Lacritin’s bioactivity. Preclinical data showed that, when Lacripep was added topically to eyes of dry eye animals, it restored basal tearing without irritation and healed the corneal surface of the eye. TearSolutions has now completed a first-in-human Phase I/II trial in primary Sjögren’s Syndrome, who typically have a severe and often debilitating form of Dry Eye and are known to be deficient in Lacritin (Clinicaltrials.gov: NCT03226444). The results showed a rapid improvement, as quickly as two weeks, in corneal health and a reduction in symptoms. Through interactions with the FDA two more trials are being planned, beginning with a Phase II/III trial late in 2021.