Inveltys From Kala Pharmaceuticals

The FDA has approved Inveltys (loteprednol etabonate ophthalmic suspension; Kala Pharmaceuticals, Inc) 1% to treat postoperative inflammation and pain.¹ About 8 million ocular surgeries occurred in the United States in 2017, more than half of which were cataract surgeries. The number of ocular surgeries is expected to grow to 10 million by 2022. Ocular corticosteroids are part of the standard of care for postoperative inflammation and pain after eye surgery. Inveltys uses Kala’s proprietary mucus-penetrating particle technology to enhance penetration of the medication into target tissues of the eye. It is the first ocular corticosteroid with twice-daily administration to be approved for postoperative inflammation and pain. All other postoperative corticosteroids require a 4-times-a-day dosing for this indication.²

PHARMACOLOGY AND PHARMACOKINETICS

Although glucocorticoids are known to activate and bind to the glucocorticoid receptor, their exact molec- ular mechanism in the role of inflammation is not clearly defined. It is believed that glucocorticoids exert their anti-inflammatory effect through the inhibition of prostaglandin production via several independent pathways. After twice-daily dosing in both eyes for 14 days, Inveltys plasma concentrations were below the limit of quantitation (1 mg/mL) at all times.¹

DOSAGE AND ADMINISTRATION

The Inveltys bottle should be shaken for 1 or 2 seconds prior to use. Patients should instill 1 to 2 drops of the medication into the affected eye twice daily beginning the day after surgery. Treatment with Inveltys should continue throughout the first 2 weeks of the postoperative period.¹

CLINICAL TRIALS

Inveltys was studied in 2 double-blind, multicenter, placebo-controlled, randomized trials of patients who underwent cataract surgery. Participants were assigned to use either 1 or 2 drops of Inveltys or a placebo twice daily for 14 days, with the first dose given the day after surgery. Complete resolution of inflammation and pain was assessed 4, 8, and 15 days after surgery. Upon evaluation for the resolution of ocular inflammation, a significant benefit was seen in those using Inveltys at days 8 and 15 compared with a placebo. Upon evaluation for the resolution of ocular pain, a significant benefit was seen in those using Inveltys at days 4, 8, and 15 compared with a placebo.¹

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

The use of Inveltys is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella. It is also contraindicated in fungal diseases of ocular structures and mycobacterial infection of the eye.

Extended ocular corticosteroid use may lead to glaucoma with optic nerve damage, as well as defects in fields of vision and visual acuity. Intraocular pressure should be monitored if Inveltys is used for 10 days or longer, and the medication should be used cautiously in patients with preexisting glaucoma. The use of corticosteroids may result in posterior subcapsular cataract formation. Treatment with corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. In diseases that cause thinning of the cornea or sclera, perforations have occurred with the use of topical corticosteroids. The initial prescription and its renewal should be made by a physician only after the patient is examined using magnification. Prolonged corticosteroid use may increase the risk of secondary ocular infections and may enhance existing infections or mask purulent symptoms. Inveltys should be used cautiously in patients with a history of herpes simplex, as ocular corticosteroids may prolong the course and may worsen the severity of many viral infections of the eye. Fungal infections of the cornea are particularly prone to developing with the long-term use of ocular corticosteroids. Because the preservative in Inveltys can be absorbed by soft contact lenses, patients should remove those prior to administration. Lenses can be reinserted 15 minutes after instillation.

The most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%). These may have resulted from the surgery.¹

Monica Holmberg, PharmD, BCPS, earned her PharmD 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.