The Food and Drug Administration (FDA) has accepted for review the New Drug Application for Eysuvis™ (loteprednol etabonate ophthalmic suspension; Kala Pharmaceuticals) 0.25% for the treatment of dry eye disease.
The investigational ophthalmic agent has been evaluated in one phase 2 and three phase 3 trials, the most recent of which (STRIDE 3) included 901 patients with dry eye disease. In April 2020, the FDA issued a Complete Response Letter to the Company indicating that positive data from additional trials were needed to support resubmission.
The STRIDE 3 study compared treatment with Eysuvis 0.25% to placebo for 2 weeks. Full results from the study have not yet been announced, but the Company states the trial met its primary end point demonstrating statistically significant improvement in ocular discomfort.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review. Kim Brazzell, PhD, CMO of Kala Pharmaceuticals said, “We are very appreciative that the Agency set a standard Class 2 review timeline, despite the ongoing pandemic, and we look forward to working together through their review of our NDA submission.”
In January 2019, Kala received approval for another formulation of loteprednol etabonate ophthalmic suspension. Inveltys is indicated for the treatment of postoperative inflammation and pain following ocular surgery.
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