FDA rejects Kala’s dry eye NDA, requests additional data
The FDA is requiring Kala Pharmaceuticals to complete an additional clinical trial of KPI-121 0.25%, its candidate for the temporary relief of dry eye signs and symptoms, according to a press release.
A complete response letter from the FDA regarding the company’s new drug application indicated that efficacy data from an additional trial will be necessary to support a resubmission, the release said.
The NDA included data from a phase 2 trial and two phase 3 efficacy and safety trials.
A phase 3 clinical trial is currently underway and continues enrolling patients, with topline data expected by the end of 2019. A resubmission of the NDA is expected in the first half of 2020.
“We remain confident in the potential of KPI-121 0.25% to be the first approved product for the temporary relief of the signs and symptoms of dry eye disease,” Kim Brazzell, Kala chief medical officer, said in the release. “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.”