Currently Enrolling Trials
Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% utilizes Kala's AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the ocular surface. LE is a corticosteriod.
Eysuvis is specifically indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
Eysuvis is supplied as a suspension for topical administration. Instill one to two drops of Eysuvis into each eye four times daily for up to two weeks.
Mechanism of Action
Eysuvis (loteprednol etabonate) is a corticosteroid. Corticosteroids inhibit the inflammatory response to a variety of inciting agents and delay or slow healing. Corticosteroids inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production.
The most common adverse reaction associated with the use of Eysuvis for two weeks was instillation site pain.
Clinical Trial Results
The FDA approval of Eysuvis was based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, and was conducted in approximately 2,900 patients with dry eye disease. Statistical significance was achieved after two weeks of dosing for the sign endpoint of conjunctival hyperemia in all three Phase 3 trials. Statistical significance was observed in two of the three Phase 3 trials for the symptom endpoints of ocular discomfort severity in both the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline.