VARENICLINE SOLN,NASAL
Clinical Criteria Summary
Document 381
Exclusion Criteria
- Nasal or sinus conditions that may interfere with administration
Inclusion Criteria
- Provider is a VA/VA Community Care ophthalmologist or optometrist
- Diagnosis of dry eye disease
- Documented lack of therapeutic response to at least two artificial tear agents from different categories OR documented corneal surface damage while frequently using artificial tear agent(s)
- Lack of response to an adequate trial of ophthalmic cyclosporine unless unable to use (e.g., intolerance, etc.)
- Lack of response to an adequate trial of lifitegrast unless unable to use (e.g., intolerance, etc.)
Document 382
Indication
- Treatment of the signs and symptoms of dry eye disease
Dosage & Administration
- Nasal spray delivering 0.03 mg varenicline per spray (0.05 mL)
- One spray in each nostril twice daily, approximately 12 hours apart
- Concomitant use of artificial tears is permitted
Patient Selection Parameters
- Dry eye disease defined by: anesthetized Schirmer’s score ≤10 mm/5 min; Ocular Surface Disease Index (OSDI) ≥23; corneal fluorescein staining (CFS) ≥2 in at least 1 corneal region or sum ≥4 for all corneal regions
- Patients who wish to use or are currently using artificial tears
Exclusions
- Corneal epithelial defects
- Chronic or recurrent epistaxis, coagulation disorders
- Prior nasal or sinus surgery
- Vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction
- Current treatment with nasal continuous positive airway pressure (CPAP)
- Intraocular or extraocular surgery within 3 months, or refractive surgery within 12 months
- Blepharoplasty or corneal transplant in either eye
- Contact lens use within 7 days prior to initiation or anticipated during treatment
- Any form of punctal or intracanalicular occlusion
Place in Therapy & Formulary Considerations
- Projected place in therapy: Patients with dry eye disease who have not responded to or tolerated treatment with topical cyclosporine and lifitegrast
- Long-term safety data beyond 84 days are needed; development of tolerance over time is unknown
Safety & Administration Monitoring
- No boxed warnings or contraindications
- Most common adverse events: sneezing (82%), cough (16%), throat irritation (13%), instillation-site (nose) irritation (8%)
- Discontinuation due to adverse events: 2% for varenicline vs 2.1% for vehicle
- Requires specific administration technique to prevent errors: insert applicator into left or right nostril, tilt tip toward top of ear on same side, do not press against nasal wall, leave space between tip and nasal wall, place tongue to roof of mouth, breathe gently while pressing/releasing applicator once