Eysuvis From Kala Pharmaceuticals, Inc

The FDA has approved Eysuvis (loteprednol etabonate ophthalmic suspension, from Kala Pharmaceuticals, Inc) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease.

Its approved duration of treatment is up to 2 weeks.¹ Dry eye disease affects the ocular surface and tears. The condition often involves discomfort, inflammation, ocular surface damage, tear film instability, and visual disturbances. About 80% of patients with dry eye disease report episodic flares, which may be caused by a range of triggers.²

PHARMACOLOGY AND PHARMACOKINETICS

Eysuvis is a corticosteroid. After 2 weeks of treatment, plasma concentrations of Eysuvis were below the limit of quantitation (1 ng/mL) at all times.¹ Eysuvis uses Kala Pharmaceuticals’ Amplify mucus-penetrating particle drug delivery technology to enhance the penetration of the medication into the target tissue on the surface of the eye.²

DOSAGE AND ADMINISTRATION

Eysuvis is dosed as 1 to 2 drops in each eye 4 times daily. The bottle should be shaken for 2 to 3 seconds before use. Patients using additional eye drops should be counseled to wait at least 5 minutes between the instillation of Eysuvis and other medications. Eysuvis is supplied as an ophthalmic suspension containing 2.5 mg/mL of loteprednol etabonate.1

CLINICAL TRIALS

The efficacy and safety of Eysuvis were evaluated in 4 double-masked, multicentered, placebo-controlled, randomized trials. About 2900 participants with dry eye disease were randomized in a 1:1 ratio to receive either Eysuvis or a vehicle 4 times a day for 2 weeks. Treatment with artificial tears during the trial was not allowed. After 2 weeks of treatment, all the phase 3 trials demonstrated a statistically significant change in conjunctival hyperemia in the Eysuvis group compared with the vehicle group. In addition, 2 trials found a statistically significant change in ocular discomfort severity in the participants using Eysuvis compared with those using the vehicle.^1,2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

As with other ophthalmic corticosteroids, treatment with Eysuvis is contraindicated in most viral diseases of the conjunctiva and cornea, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella. It is also contraindicated in fungal diseases of the ocular structures and mycobacterial infection of the eye.

Treatment with ocular corticosteroids can delay healing and cause corneal and scleral thinning, which may lead to perforation. The initial prescription and each renewal should be made by a physician only after examination with the aid of magnification, such as slit lamp biomicroscopy, and fluorescein staining as clinically warranted. Eysuvis should be used cautiously in patients with glaucoma. Extended corticosteroid use may result in glaucoma with optic nerve damage and visual defects. Renewal of the Eysuvis prescription should be made by a physician only after examination and evaluation of the intraocular pressure. Treatment with ocular corticosteroids may increase the risk of secondary ocular infections and may result in posterior subcapsular cataract formation. In acute purulent conditions of the eye, corticosteroid use may enhance or mask infection. Treatment with ocular corticosteroids may exacerbate and extend viral infections of the eye, including herpes simplex. Caution is advised if Eysuvis is used in patients with a history of herpes simplex. Corneal fungal infections may occur coincidentally with long-term ocular corticosteroid use. A fungal infection must be considered in any persistent corneal ulceration during or after corticosteroid treatment, and fungal cultures should be taken when appropriate. To prevent contamination of the suspension, the dropper tip should not touch any surface. Contact lenses should be removed before administration of Eysuvis and may be reinserted 15 minutes after dosing.

After 2 weeks of treatment with Eysuvis, the most common adverse drug reaction was instillation site pain.¹

MONICA HOLMBERG, PHARMD, BCPS, earned her pharmacy degree at the University of Connecticut in Storrs and completed an ambulatory care residency at the Phoenix VA Health Care System in Arizona. Her practice has also included pediatrics and inpatient mental health. She lives in Phoenix.

REFERENCES

• Eysuvis. Prescribing information. Kala Pharmaceuticals, Inc; 2020. Accessed October 28, 2020. https://eysuvis.com/pdf/prescribing- information.pdf
• Kala Pharmaceuticals announces FDA approval of Eysuvis for the short-term treatment of the signs and symptoms of dry eye disease. News release. Kala Pharmaceuticals, Inc; Oct. 27, 2020. Accessed October 29, 2020. https:// investors.kalarx.com/news-releases/news-release- details/kala-pharmaceuticals-announces- fda-approval-eysuvistm-short-term