Neurotrophic Keratitis Treatment Gains FDA Fast Track
TearSolutions wins FDA designations for Lacripep in NK
Clinical Scorecard: Neurotrophic Keratitis Treatment Gains FDA Fast Track
At a Glance
| Category | Detail |
|---|
| Condition | Neurotrophic Keratitis |
| Key Mechanisms | Reduced or absent corneal sensitivity and impaired corneal healing. |
| Target Population | Patients with neurotrophic keratitis, a rare degenerative corneal disease. |
| Care Setting | Clinical-stage biotechnology development. |
Key Highlights
- Lacripep has received Orphan Drug and Fast Track designations from the FDA.
- Phase 2 clinical trial initiated with first patients dosed.
- Lacripep is a synthetic peptide derived from lacritin.
- Study expected to enroll approximately 54 participants.
Guideline-Based Recommendations
Diagnosis
Management
Monitoring & Follow-up
Risks
Patient & Prescribing Data
Patients with neurotrophic keratitis.
Clinical Best Practices
- Utilize FDA designations to expedite clinical development.
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