The Food and Drug Administration (FDA) has approved Eysuvis™ (loteprednol etabonate ophthalmic suspension 0.25%; Kala Pharmaceuticals) for the short-term (up to 2 weeks) treatment of the signs and symptoms of dry eye disease.

Eysuvis utilizes the Company’s proprietary technology to enhance penetration into the target tissue of the ocular surface. Loteprednol etabonate targets the immune responses that lead to acute dry eye disease flares.

The approval was based on data from 4 clinical trials, including three phase 3 trials (STRIDE 1, STRIDE 2 and STRIDE 3) and one phase 2 trial, evaluating the efficacy and safety Eysuvis in approximately 2900 patients with dry eye disease. Patients were randomized 1:1 to receive either Eysuvis or vehicle 4 times daily for 2 weeks.

Results from these clinical trials showed that treatment with Eysuvis was associated with significant improvements in both the signs and symptoms of dry eye disease. Following 2 weeks of dosing with Eysuvis, statistically significant improvements in conjunctival hyperemia were observed in all phase 3 studies. Additionally, statistically significant improvements in ocular discomfort were demonstrated in 2 of the 3 studies. As for safety, Eysuvis was well tolerated with the most common adverse reaction being instillation site pain reported in 5% of patients.

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Eysuvis will be supplied as 2.5mg/mL of loteprednol etabonate in an 8.3mL suspension. The Company plans to launch the product by the end of the year.

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  1. Kala Pharmaceuticals announces FDA approval of Eysuvis™ for the short-term treatment of the signs and symptoms of dry eye disease. [press release]. Watertown, MA: Kala Pharmaceuticals; October 27, 2020. 
  2. Eysuvis [package insert]. Watertown, MA: Kala Pharmaceuticals; 2020.