Kala Pharmaceuticals Posts KPI-012 Data In Healing Impaired Ocular Diseases

Kala Pharmaceuticals Inc KALA reported data from a Phase 1b trial of KPI-012, a cell-free secretome therapy for severe ocular diseases driven by impaired healing.
As previously disclosed, KPI-012 was well tolerated and resulted in significant improvements in various persistent corneal epithelial defect (PCED) etiologies.
The data will be presented at the 2022 Association for Research in Vision and Ophthalmology.
KPI-012 resulted in the complete healing of PCED in 6 of 8 participants.
Improvement in PCED lesion size was observed in those participants who did not heal completely.
All six healed participants remained healed through the end of the follow-up.
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Participants had a mean (SD) improvement in lesion size of -16.23 (12.38) mm2.
The mean improvement in BCDVA was -0.38 (0.88) logMAR.
5 of 8 participants (62.5%) improved their corneal opacity scores from baseline to end of treatment, and 1 had no change in score.
100% reported pain reduction by Week 1. There was only one TEAE reported, and it was mild and transient
The company is on track to submit FDA Investigational New Drug Application (IND) and initiate the Phase 2/3 Trial in 4Q 2022.
Price Action: KALA shares are up 9.31% at $0.71 during the market session on the last check Monday.