The U.S. Food and Drug Administration has approved loteprednol etabonate ophthalmic suspension (Eysuvis; Kala Pharmaceuticals, Inc) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease.
Approval was based on the results of three Phase 3 trials and one Phase 2 trial that demonstrated significant improvements in the signs and symptoms of dry eye disease. After 2 weeks of dosing, statistical significance was achieved for the endpoint of conjunctival hyperemia in the Phase 3 trials. In the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline, statistical significance was observed for the symptom endpoints of ocular discomfort severity in 2 of the 3 Phase 3 trials.
“The FDA approval of Eysuvis as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major accomplishment for Kala and an important moment for patients, who have been waiting for an FDA-approved, safe, effective and fast-acting therapy,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals in a press release. “As we prepare to launch Eysuvis, we will leverage our strong foundation of highly experienced ophthalmology marketing, sales and market access professionals with the goal of establishing Eysuvis as the preferred, first-line prescription therapy for dry eye disease. We’d like to thank the many patients and investigators that were involved in the clinical trials that led to this important milestone.”
Read the full press release here.