WATERTOWN, MA — Kala Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has approved Eysuvis 0.25% for short-term treatment of signs and symptoms of dry eye disease.
“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, CEO of Kala Pharmaceuticals.
“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.”
Eysuvis (loteprednol etabonate ophthalmic suspension) uses Kala’s Ampplify mucus-penetrating particle drug delivery technology to enhance penetration of loteprednol etabonate into target tissue on the ocular surface. Loteprednol etabonate targets the immune responses that drive acute dry eye disease flares, according to a press release from the company.
“Prior to EYSUVIS, there were no FDA-approved ocular corticosteroids for the treatment of dry eye disease,” the release explains.
Kala (NASDAQ: KALA) plans to launch Eysuvis in the U.S. by the end of the year.
“Dry eye disease can significantly decrease quality-of-life among affected patients and drive decreased workplace productivity, contact lens intolerance and discontinuation, and poor cataract and refractory surgery outcomes,” said Kelly Nichols, OD, dean of the University of Alabama at Birmingham School of Optometry. “As the prevalence of dry eye disease increases, there is a tremendous need for new therapies to manage mild-to-moderate dry eye disease patients, many of whom currently go untreated. I am excited by the approval of EYSUVIS and confident that having access to an approved corticosteroid specifically for dry eye disease will meaningfully impact the management of patients across the U.S.”
The FDA granted approval to Eysuvis based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease. The drug is approved for short-term (up to two weeks) treatment, the company explains.