Business
Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
-- Enrolled first patient in CHASE Phase 2b clinical trial evaluating KPI-012 for PCED; Top-line data targeted for 1Q 2024 -- -- Closed $31.0 million private
About this update from Kala Bio, Inc.
[{"type":"text","content":"-- Enrolled first patient in CHASE Phase 2b clinical trial evaluating KPI-012 for PCED; Top-line data targeted for 1Q 2024 -- -- Closed $31.0 million private placement financing, extending cash runway into 1Q 2025 -- ARLINGTON, Mass., March 03, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update. “2022 was a transformational year for Kala. In the third quarter, we completed the sale of EYSUVIS® and INVELTYS® to Alcon Inc., enabling us to devote our full attention to developing innovative therapies, including KPI-012, for rare and severe eye diseases,” said Mark Iwicki, Chief Executive Officer and Chairman of Kala Pharmaceuticals. “In the months since, we made great progress advancing KPI-012 for the treatment of persistent corneal epithelial defect (PCED), a rare and debilitating ocular condition. We recently enrolled the first patient in our CHASE Phase 2b clinical trial of KPI-012, potentially the first of two pivotal studies required to support an application for marketing approval in the United States, and we are targeting top-line safety and efficacy data in the first quarter of 2024. In addition, following the completion of our $31.0 million private placement financing in the fourth quarter of 2022 and coupled with our streamlined corporate structure, we are operating from a position of financial strength, with capital well beyond the anticipated readout from the CHASE trial.” Fourth Quarter and Recent Business Highlights: Development-Stage Pipeline:In February 2023, Kala dosed the first patient in its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for PCED in the United States. The CHASE Phase 2b clinical trial is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) compared to vehicle when dosed topically four times per day (QID) for 56 days. After the first cohort with two initial patients to evaluate the safety of the high dose, patients in the...