The FDA on Tuesday approved Kala Pharmaceuticals’ Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%), making it the first ocular corticosteroid for the treatment of dry eye disease and the first drug approved specifically for the short-term (up to 2 weeks) treatment of the signs and symptoms of dry eye disease.
Kala Pharmaceuticals plans to launch Eysuvis in the United States by year-end.
“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,” Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals, said in a company news 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.”
Approximately 80 percent of people living with dry eye disease suffer from episodic flares. These flares can be caused by a wide variety of triggers and often cannot be adequately managed with current therapies, according to Kala Pharmaceuticals.
Eysuvis utilizes Kala’s Ampplify mucus-penetrating particle (MPP) 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. Prior to Eysuvis, there were no FDA-approved ocular corticosteroids for the treatment of dry eye disease.
“The approval of Eysuvis ushers in a new era in the treatment of dry eye disease and offers promise to the millions of dry eye patients who experience acute exacerbations, or flares, of their disease each year,” Edward Holland, MD, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati, said in the news release. “For the first time we will be able to offer dry eye patients a therapeutic option that provides rapid relief for both the signs and symptoms of the disease and that is safe and well tolerated.”
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. Specifically, statistical significance was achieved after 2 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. Eysuvis was well-tolerated across the four trials, with adverse events and intraocular pressure increases comparable to that observed with vehicle.
Eysuvis becomes just the fourth FDA approved drug for dry eye disease, joining Restasis (Allergan), Xiidra (Novartis), and Cequa (Sun Pharma).
“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, MPH, PhD, FAAO, 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.”