KALA BIO has formally appointed Todd Bazemore as President and Chief Executive Officer, ending his interim tenure that began in February 2025. The leadership transition comes as the clinical-stage biopharmaceutical company approaches a pivotal Phase 2b trial readout for its lead therapeutic candidate targeting rare ocular diseases.
Leadership Transition at Critical Juncture
Mark Iwicki, Chair of KALA BIO's Board of Directors, emphasized Bazemore's instrumental role in driving the company's clinical progress and strategy. "Todd's deep understanding of KALA, combined with over a decade of experience in rare disease and a proven track record of global commercial leadership spanning sales, marketing and market access, uniquely positions him to steer KALA through this pivotal period," Iwicki stated.
The appointment coincides with KALA's preparation for the upcoming readout of its Phase 2b CHASE trial evaluating KPI-012 for persistent corneal epithelial defect (PCED). Bazemore described this as "an important inflection point for the Company" as KALA prepares for potential transition from a clinical-stage biotechnology company toward becoming a fully integrated organization with commercial capabilities.
Addressing Unmet Medical Need in Rare Ocular Disease
KPI-012 represents KALA's lead product candidate for treating PCED, a rare disease characterized by impaired corneal healing. According to Bazemore, PCED is "an orphan condition with high unmet medical need for which there are no FDA-approved products that address all underlying etiologies." The company believes KPI-012's multifactorial mechanism of action has the potential to address all underlying causes of the condition.
The therapeutic candidate has received both Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, reflecting the regulatory agency's recognition of the significant unmet medical need in this patient population.
Proprietary Platform Technology
KPI-012 is built on KALA's proprietary mesenchymal stem cell secretome (MSC-S) platform. The human MSC-S contains numerous human-derived biofactors, including growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing underlying multiple severe ocular diseases.
Beyond PCED, KALA is targeting potential development of KPI-012 for Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision. The company has also initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, including Retinitis Pigmentosa and Stargardt Disease.
Extensive Industry Experience
Bazemore brings over 30 years of experience across ultra-rare orphan diseases to large primary care conditions. His tenure at KALA began in November 2017 as Chief Operating Officer before assuming the interim CEO role in February 2025.
Prior to joining KALA, Bazemore served as Executive Vice President and Chief Operating Officer of Santhera Pharmaceuticals (USA), Inc. from September 2016 to November 2017. He also held the position of Executive Vice President and Chief Commercial Officer at Dyax Corp. from April 2014 to January 2016, where he was responsible for global commercial strategy until the company's acquisition by Shire plc.
Earlier in his career, Bazemore spent 11 years at Sunovion Pharmaceuticals, Inc. (previously Sepracor Inc.), where he launched seven new products while serving in roles of increasing responsibility, including Vice President positions in Managed Markets, Sales, and the Respiratory Business Unit.
Commercial Readiness Strategy
The company believes the upcoming Phase 2b CHASE trial could serve as a pivotal trial to support the submission of a Biologics License Application (BLA) to the FDA. This potential regulatory pathway underscores the significance of the approaching data readout for KALA's commercial prospects.
Bazemore emphasized that the MSC-S platform "represents a potential transformative approach to treating rare and severe ocular diseases beyond PCED for multiple conditions in both the anterior and posterior segments of the eye," suggesting broader therapeutic applications for the company's technology platform.
