Dry eye:
Indications for: EYSUVIS
Short-term (up to 2wks) treatment of the signs/symptoms of dry eye disease.
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.
Adult Dosage:
Instill 1–2 drops into each eye 4 times daily for up to 2wks.
Children Dosage:
Not established.
EYSUVIS Contraindications:
Ocular fungal, viral, or mycobacterial infections.
EYSUVIS Warnings/Precautions:
Prescribe initially and renew only after appropriate examination. Corneal or scleral thinning. Glaucoma. History of herpes simplex. May mask or exacerbate ocular infections. Monitor IOP and for secondary infections in prolonged therapy. Remove soft contact lenses prior to therapy; may reinsert 15mins after dose. Pregnancy. Nursing mothers.
EYSUVIS Classification:
Steroid.
Adverse Reactions:
Instillation site pain; increased IOP, cataract formation, ocular infections.
Generic Drug Availability:
NO
How Supplied:
Susp—8.3mL (in 10mL bottle)
