Eysuvis Generic Name & Formulations
Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze.
The white tamper-evident overcap can be thrown away. Retain the pink cap and keep the bottle tightly closed when not in use.
After opening, Eysuvis can be used until the expiration date on the bottle.
Eysuvis Dosage and Administration
Eysuvis Boxed Warnings
Delayed Healing and Corneal Perforation
- Corticosteroids may delay healing and cause corneal and scleral thinning.
- Use of topical corticosteroids in the presence of corneal or scleral thinning may lead to perforation.
- Initial prescription and each renewal of medication should be made after examination of the patient with the aid of magnification, and, where appropriate, fluorescein staining.
Intraocular Pressure (IOP) Increase
- Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision.
- Use with caution in the presence of glaucoma.
- Renewal of medication should be made only after examination of the patient and evaluation of IOP.
- Use of corticosteroids may result in posterior subcapsular cataract formation.
- Risk of secondary ocular infections increased as corticosteroids suppress the host response.
- Corticosteroids may mask infection or enhance existing infection in acute purulent conditions of the eye.
- History of herpes simplex: use caution.
- Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
- Long-term local corticosteroid application: fungal infections of the cornea may develop.
- Consider fungus invasion in any persistent corneal ulceration where a corticosteroid has been used or is in use.
- Fungal cultures should be taken when appropriate.
Risk of Contamination
- Do not allow the dropper tip to touch any surface, as this may contaminate the suspension.
Contact Lens Wear
- The preservative in Eysuvis may be absorbed by soft contact lenses.
- Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.
There are no adequate and well controlled studies with loteprednol etabonate in pregnant women.
Nursing Mother Considerations
There are no data on the presence of loteprednol etabonate in human milk, the effects on the breastfed infant, or the effects on milk production.Consider the benefits to the mother vs the risks to the infant.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
Following bilateral topical ocular dosing of 2 drops of Eysuvis 4 times a day for 14 days in 20 healthy adults, the plasma concentrations of loteprednol etabonate were below the limit of quantitation (1ng/mL) at all timepoints.
Eysuvis Adverse Reactions
Eysuvis Clinical Trials
The approval was based on data from 4 clinical trials, including three phase 3 trials (STRIDE 1, STRIDE 2 and STRIDE 3) and one phase 2 trial, evaluating the efficacy and safety of Eysuvis in approximately 2900 patients with dry eye disease. Patients were randomly assigned 1:1 to receive either Eysuvis or vehicle 4 times daily for 2 weeks.
Results from these clinical trials showed that treatment with Eysuvis was associated with significant improvements in both the signs and symptoms of dry eye disease. Following 2 weeks of dosing with Eysuvis, statistically significant improvements in conjunctival hyperemia were observed in all phase 3 studies. Additionally, statistically significant improvements in ocular discomfort were demonstrated in 2 of the 3 studies.
Eysuvis Patient Counseling
Shake the bottle for 2 to 3 seconds before using.
Wash hands before use; do not allow dropper tip to touch any surface.
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.