CENEGERMIN-BKBJ SOLN,OPH
Clinical Criteria Summary
Exclusion Criteria
- Active ocular infection
- Active ocular inflammation not related to neurotrophic keratitis
- Non-approved conditions (e.g., dry eye, glaucoma, retinitis pigmentosa)
Inclusion Criteria
- Provider is an ophthalmologist (VA or VA authorized community care)
- Diagnosis of stage 2 or stage 3 neurotrophic keratitis
- Refractory to treatment to regularly scheduled preservative-free artificial tears, gels, or ointments
- Refractory to treatment with topical cyclosporin (if use is appropriate)
- Refractory to treatment with at least ONE of the following: corneal or scleral therapeutic contact lenses, punctal-occlusion, non-surgical (e.g., patching, botulinum induced ptosis) or surgical (tarsorrhaphy) eyelid closure, or other intervention
- Willingness to comply with cenegermin administration schedule (6 times a day at 2-hour intervals for eight weeks)
- One-time renewal may be considered on a case-by-case basis for recurrence in a patient who had demonstrated compliance with the administration regimen
- Discontinue benzalkonium chloride (BAK)-preserved topical ophthalmic medications where feasible
- Discuss with patient the use of alarms or other reminders to support adherence to therapy
- No data on outcomes for retreatment of recurrences defined as Stage 2 or 3 NK after complete healing has occurred and treatment has been stopped