TearSolutions advances Lacripep into phase 2 following dual FDA designations in neurotrophic keratitis

TearSolutions, Inc. has announced that the FDA has granted both Orphan Drug Designation (ODD) and Fast Track Designation for a topical synthetic peptide (Lacripep) in neurotrophic keratitis (NK), and that the company has initiated a phase 2 clinical trial with the first patients dosed.¹

NK is a rare degenerative corneal disorder in which reduced or absent corneal sensitivity impairs epithelial healing, potentially resulting in persistent epithelial defects and vision loss.¹

Regulatory designations

The FDA’s ODD provides a range of incentives for the development of treatments for rare diseases, including tax credits for qualified clinical testing and up to 7 years of US market exclusivity upon regulatory approval.¹ The Fast Track Designation facilitates more frequent interactions with the FDA and enables a rolling review of the New Drug Application, with the aim of expediting the development and review process for drugs that treat serious conditions.¹

Anil Asrani, chief executive officer of TearSolutions, said in the announcement: “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 [this topical synthetic peptide] to transform how this disease is treated. 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.”¹

Phase 2 clinical trial

The phase 2 clinical trial is a multicenter, randomized, vehicle-controlled study designed to evaluate the safety and efficacy of the topical synthetic peptide in patients with NK. Approximately 54 subjects will be enrolled. The trial has been initiated in the US; further information is available at ClinicalTrials.gov under identifier NCT07568730.¹

About the topical synthetic peptide

The agent is described by the company as a novel, first-in-class topical synthetic peptide derived from the human tear protein lacritin. In preclinical and early clinical studies, the agent’s proposed dual neurotrophic and prosecretory functions aim to resolve underlying nerve damage, reactivate physiological basal tear secretion, and restore health to the corneal epithelium.¹ The peptide was discovered at the University of Virginia with funding from the National Institutes of Health National Eye Institute as a naturally occurring fragment of lacritin, a 119 amino acid protein, identified in an unbiased screen for novel factors capable of addressing ocular surface disease.¹

TearSolutions had previously announced plans to conduct phase 2/3 trials of the topical synthetic peptide in dry eye disease, including in patients with primary Sjögren syndrome, following a phase 1/2 first-in-human trial and a Type C meeting with the FDA.²

References

1. TearSolutions receives FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis and initiates phase 2 clinical trial with first patients dosed. News release. TearSolutions. June 2, 2026. Accessed June 2, 2026. https://tearsolutions.com/wp-content/uploads/2026/06/TearSolutions_PressRelease_June2026_FINAL-1.pdf

2. Hutton D. TearSolutions planning phase II/III trials for therapy to treat dry eye disease. Ophthalmology Times. February 25, 2022. Accessed June 2, 2026. https://www.ophthalmologytimes.com/view/tearsolutions-planning-phase-ii-iii-trials-for-therapy-to-treat-dry-eye-disease