FDA wants additional data on Kala Pharma's KPI-121

9 August 2019

There was disappointment for US drug developer Kala Pharmaceuticals (Nasdaq: KALA), as it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for KPI-121 0.25% 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, with the news sending Kala’s shares down 9.98% to $4.69 by close of trading on Thursday, and seeing a further 11.96% fall to $4.05 in after-hours trading

Kala says it 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 top-line data from STRIDE 3 by the end of 2019 and resubmission of the NDA during the first half of 2020.

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