FDA Approves Short-Term Treatment for Dry Eye Disease Symptoms

Eysuvis is the first prescription therapeutic to specifically address short-term needs for patients with dry eye disease, a chronic condition affecting the tears and ocular surface.

Kala Pharmaceuticals has announced the FDA approval of loteprednol etabonate (LE) ophthalmic suspension (Eysuvis) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease.

According to a press release, this is the first prescription therapeutic to specifically address short-term needs for patients with dry eye disease, a chronic condition affecting the tears and ocular surface. It can involve tear film instability, ocular inflammation, discomfort, visual disturbance, and ocular surface damage. Approximately 80% of patients with dry eye disease have episodic flares, which can be caused by a variety of triggers and are often not adequately controlled with current therapies.

The newly approved ophthalmic solution is indicated for up to 2 weeks of use in this population. Eysuvis uses mucus-penetrating particle delivery technology to enhance penetration of LE into target tissue on the eye surface, according to the press release. LE targets the immune responses that drive acute dry eye flares.

“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,” said Edward Holland, MD, director of cornea services at Cincinnati Eye Institute, in a press 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 approval is based on results from 4 clinical trials, including 3 phase 3 trials and 1 phase 2 trial. In all of the phase 3 trials, statistically significant improvements in conjunctival hyperemia was achieved after 2 weeks of dosing. Improvements in 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 was also observed in 2 of the phase 3 trials. LE was well-tolerated across all 4 trials.

“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, in the press release. “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.”


Kala Pharmaceuticals Announces FDA Approval of Eysuvis for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease [news release]. Kala Pharmaceuticals; October 27, 2020. https://investors.kalarx.com/news-releases/news-release-details/kala-pharmaceuticals-announces-fda-approval-eysuvistm-short-term. Accessed October 27, 2020.

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