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Epi-Off
Epi-Off is a corneal cross-linking procedure that uses riboflavin and ultraviolet-A light to strengthen corneal collagen and halt progression of keratoconus.
Epi-Off is a corneal cross-linking procedure that uses riboflavin and ultraviolet-A light to strengthen corneal collagen and halt progression of keratoconus. Used for Progressive keratoconus, Corneal ectasia post-refractive surgery, Pellucid marginal degeneration.
At a glance
| Generic name | Epi-Off |
|---|---|
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Drug class | Corneal cross-linking agent |
| Target | Corneal collagen (riboflavin-mediated photochemical cross-linking) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
The treatment involves instillation of riboflavin (vitamin B2) onto the cornea followed by exposure to UVA light, which creates cross-links between collagen fibers in the corneal stroma. This increases corneal rigidity and biomechanical strength, preventing further corneal ectasia and visual deterioration in progressive keratoconus and other corneal disorders.
Approved indications
- Progressive keratoconus
- Corneal ectasia post-refractive surgery
- Pellucid marginal degeneration
Common side effects
- Corneal haze
- Temporary vision reduction
- Dry eye
- Pain/discomfort during healing
Key clinical trials
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Oral Versus Intramuscular Steroid Use to Control Rheumatoid Arthritis Flares (PHASE4)
- Phase 2 Study to Assess the Safety and Efficacy of ANG003 (PHASE2)
- THE MALABSORPTION BLOOD TEST TRIAL WILL HELP DETERMINE THE BENEFITS OF PANCREATIC ENZYME REPLACEMENT THERAPY IN PATIENTS WITH MILD TO MODERATE EXOCRINE PANCREATIC INSUFFICIENCY. (PHASE4)
- Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases (PHASE3)
- Evaluation of a New MRI Technique to Reduce Breathing-Related Artifacts in Brain Imaging
- PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus (NA)
- Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |