FDA rejects Kala’s dry eye NDA, requests additional data
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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 …
Read More: FDA rejects Kala’s dry eye NDA, requests additional data