Lacripep gains FDA designations as phase II trial begins in neurotrophic keratitis

The investigational topical peptide is now being evaluated in a US phase II study focused on stage 1 neurotrophic keratitis

Lacripep has received US Food and Drug Administration (FDA) orphan drug and fast track designations for neurotrophic keratitis (NK), as TearSolutions begins dosing patients in a phase II clinical trial of the investigational topical therapy.¹

The designations could support a more efficient development pathway for Lacripep if emerging clinical data are positive. Orphan drug status reflects the rarity of NK and may provide development incentives, while fast track designation allows closer engagement with the FDA during clinical development and may support an accelerated review process if the therapy advances to a future regulatory submission.

NK is a rare, degenerative corneal disease caused by impaired trigeminal corneal innervation, resulting in reduced corneal sensitivity, epithelial breakdown and poor healing. Disease progression can lead to persistent epithelial defects, corneal ulceration, stromal melting, perforation and vision loss.² For ophthalmologists, particularly those managing corneal and ocular surface disease, the condition remains challenging because symptoms can be limited despite clinically significant corneal damage.

The ongoing phase II study is a multicenter, randomized, vehicle-controlled trial evaluating the safety and efficacy of Lacripep in patients with NK. ClinicalTrials.gov lists the trial as assessing Lacripep 4 μM ophthalmic solution versus vehicle in patients with stage 1 NK, with an estimated enrollment of 54 participants.

Lacripep is a synthetic peptide derived from lacritin, a naturally occurring human tear protein. TearSolutions is developing the therapy with the aim of addressing impaired corneal nerve function, supporting basal tear production and improving epithelial health. However, the treatment remains investigational, and the phase II trial will be an important test of whether this proposed mechanism translates into measurable benefit in early-stage NK.

The update adds to ongoing interest in therapies that target the underlying neurotrophic component of NK, rather than focusing solely on ocular surface protection and epithelial repair. Further data from the phase II program will be needed to clarify Lacripep’s potential role in the future treatment pathway.

References:

1. 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. Press release. June 2, 2026. Available at: https://www.businesswire.com/news/home/20260602334989/en/TearSolutions-Receives-FDA-Orphan-Drug-and-Fast-Track-Designations-for-Lacripep-in-Neurotrophic-Keratitis-and-Initiates-Phase-2-Clinical-Trial-with-First-Patients-Dosed (Accessed June 5, 2026).
2. Versura P, Giannaccare G, Pellegrini M, Sebastiani S, Campos EC. Neurotrophic keratitis: current challenges and future prospects. Eye Brain. 2018;10:37–45. doi: 10.2147/EB.S117261. PMID: 29988714.