FDA approves Eysuvis for short-term dry eye disease treatment
The FDA has approved Eysuvis for the short-term treatment of dry eye disease signs and symptoms, according to a press release from Kala Pharmaceuticals.
Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%) is the first ocular corticosteroid approved by the FDA for the treatment of dry eye disease. Kala is planning to launch it in the U.S. by the end of the year.
The approval is based on results from four clinical trials that demonstrated significant improvement in signs and symptoms of dry eye disease. Eysuvis is approved for up to 2 weeks of treatment.
In three phase 3 trials, “statistical significance was achieved after 2 weeks of dosing for the sign endpoint of conjunctival hyperemia,” the release said. For the symptom endpoint of ocular discomfort severity, statistical significance was reached in two of the phase 3 trials.
Eysuvis was well tolerated in the four trials. Adverse events and IOP increases were comparable to those seen with vehicle.