FDA provides complete response to filing of KPI 121 0.25% in dry eye disease
Kala Pharmaceuticals has received a complete response letter (CRL) from the FDA regarding the Company’s new drug application for KPI 121 0.25% (nanoparticle loteprednol etabonate) for the temporary relief of the signs and symptoms of dry eye disease. The FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.
Kala continues to enroll patients in its ongoing STRIDE 3 (STRIDE – Short Term Relief In Dry Eye) Phase III clinical trial, and expects this trial will serve as the basis of its response to the CRL. Kala is targeting topline data from STRIDE 3 by the end of 2019 and resubmission of the NDA during the first half of 2020. The Company believes this resubmission would be subject to a six-month review under the Prescription Drug User Fee Act.
Comment: Kala initiated STRIDE 3 in July 2018 at the recommendation of the FDA. The STRIDE 3 trial design reflects specific modifications to the inclusion and exclusion criteria of Kala’s previous trials of KPI-121 0.25%, which were implemented to improve the probability of success.
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