Research & Development
Kala Pharmaceuticals receives complete response letter from the US FDA for KPI-121 0.25 percent new drug application
12 August 2019 -

United States-based Kala Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease, it was reported on Friday.

The US FDA has indicated that efficacy data from an additional clinical trial will be required to support a resubmission. The company continues to enrol patients in its ongoing STRIDE three (STRIDE – Short Term Relief In Dry Eye) Phase three clinical trial, and expects this trial will serve as the basis of its response to the CRL. The company is aiming at top line data from STRIDE three by the end of 2019 and resubmission of the NDA application during the first half of 2020. It believes this resubmission is to be subjected to a six-month review under the Prescription Drug User Fee Act. The STRIDE three trial design indicates specific modifications to the inclusion and exclusion criteria of the company's earlier trials of KPI-121 0.25 percent, which were implemented to improve the probability of success.

Kim Brazzell, chief medical officer of Kala Pharmaceuticals, said, 'We remain confident in the potential of KPI-121 0.25 percent to be the first approved product for the temporary relief of the signs and symptoms of dry eye disease. We look forward to reporting data from STRIDE 3 and resubmitting the NDA with the goal of obtaining approval and being able to offer KPI-121 0.25% to the millions of patients with dry eye disease.'