Kala Pharmaceuticals Stock Surges 65% As FDA Accepts IND Application For KPI-012

Shares of Kala Pharmaceuticals, Inc. (KALA) surged nearly 65% on Tuesday after hours after the clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration has accepted an investigational new drug application for the company's lead product candidate, KPI-012.

KPI-012 is a human mesenchymal stem cell secretome (MSC-S), initially in development for the treatment of persistent corneal epithelial defect (PCED).

"The acceptance of the KPI-012 IND is an important milestone for Kala, as we work to translate the promise of our MSC-S platform into better outcomes for people living with rare ocular surface diseases," said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer of Kala Pharmaceuticals. "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."

The Phase 2b clinical trial will be a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution compared to vehicle when dosed topically four times per day (QID) for 56 days.

The trial is expected to enroll approximately 90 adult patients with PCED, and the primary endpoint of the trial will be complete healing of the PCED as measured by corneal fluorescein staining.

Kala expects to initiate enrollment in the trial in the first quarter of 2023 and expects to report topline data in the first quarter of 2024.

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