KALA - Kala Pharma soars ~60% after hours as FDA oks application for corneal defect treatment

• Kala Pharmaceuticals ( NASDAQ: KALA ) on Tuesday said the U.S. Food and Drug Administration (FDA) had accepted its investigational new drug application for its lead product candidate KPI-012 for the treatment of persistent corneal epithelial defect (PCED).
• Shares of the micro-cap clinical-stage biopharma surged 63.3% to $6.40 after hours.
• PCED is a complication that can result from the failure of proper closure and complete healing after a corneal injury.
• "We are now turning our focus to clinical execution. We are working closely with investigators to initiate our Phase 2b clinical trial of KPI-012 for PCED in the first quarter of 2023," KALA's chief medical officer Kim Brazzell said in a statement .
• The mid-stage trial is expected to enroll about 90 adult patients with PCED and will evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution.
• The company also said it had received a remaining $25M investment under a previously announced private placement financing.

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