Clinical Report: Neurotrophic Keratitis Treatment Gains FDA Fast Track

Overview

TearSolutions has received FDA Orphan Drug and Fast Track designations for Lacripep in neurotrophic keratitis (NK) and has initiated a Phase 2 clinical trial.

Background

Neurotrophic keratitis is characterized by reduced corneal sensitivity and impaired healing, potentially leading to vision loss. Current treatment options are limited, with cenegermin being the only FDA-approved therapy.

Data Highlights

TearSolutions has initiated a multicenter, randomized, vehicle-controlled Phase 2 trial expected to enroll approximately 54 participants.

Key Findings

• Lacripep is a synthetic peptide derived from lacritin, a human tear protein.
• The FDA’s Orphan Drug designation provides development incentives, including tax credits and potential market exclusivity.
• Fast Track designation allows for accelerated development and review for therapies targeting serious conditions.
• Preclinical studies suggest Lacripep has dual neurotrophic and prosecretory functions.
• The Phase 2 trial aims to assess Lacripep’s safety and efficacy in patients with neurotrophic keratitis.

Clinical Implications

Ongoing clinical trials will provide data on Lacripep's safety and efficacy.

Conclusion

Lacripep has received FDA designations for neurotrophic keratitis.

Related Resources & Content

1. TearSolutions, Ophthalmology Management, 2026 -- TearSolutions Receives FDA Orphan Drug Fast Track Designations for Lacripep
2. Oculis Holding AG, Retinal Physician, 2025 -- Privosegtor Receives Breakthrough Drug Designation
3. Krystal Biotech, Ophthalmology Management, 2025 -- Krystal Biotech Receives FDA Platform Technology Designation for HSV1 Viral Vector Used in KB801 for Neurotrophic Keratitis
4. Systematic Literature Review, 2026 -- Evidence base and current standard for neurotrophic keratopathy
5. PubMed, 2026 -- Medical and surgical interventions for neurotrophic keratopathy
6. Retinal Physician — Nacuity Pharmaceuticals Granted FDA Fast Track Designation for NPI-001 Tablets for Retinitis Pigmentosa
7. TearSolutions Press Release
8. Systematic Literature Review on the Effect of Cenegermin on Corneal Sensation and Innervation in Patients with Neurotrophic Keratopathy - Simon S. M. Fung, Cynthia Campos, Justin Weiss, Irina Yermilov, 2026
9. Medical and surgical interventions for neurotrophic keratopathy - PubMed