KPI-012 Overview - KPI-012 is a novel clinical-stage secretome therapy in development for Persistent Corneal Epithelial Defect (PCED)[3] - KPI-012 has potential to treat PCEDs of multiple etiologies as well as other severe ocular surface diseases[4] - There are approximately 100,000 PCED patients in the US and 238,000 in the US, EU, and Japan combined[6] - Oxervate, the only approved Rx product, is indicated for neurotrophic keratitis (NK) which is estimated to be the underlying etiology for only ~1/3 of all PCED cases[6] Clinical Trial Results - In a Phase 1b clinical trial, 7 out of 8 PCED patients showed improvement with BID dosing of KPI-012[3,13] - Complete healing of PCED was observed in 6 out of 8 patients, in most cases within 1 to 2 weeks of dosing[3,13] - Of patients reporting pain at baseline (6 of 8), 67% reported 0 pain score at Week 1, and 100% reported 0 pain score at Week 3[18] Market Opportunity and Exclusivity - The industry estimates ~100K PCED patients in the U S and ~ 238K patients in US/EU/Japan combined[19] - If approved as a new biologic product under a BLA, KPI-012 should enjoy 12 years market exclusivity for each indication[22] - A worldwide patent portfolio related to KPI-012 has a 20-year patent term ending in 2040[22]
Kala Pharmaceuticals (KALA) Investor Presentation - Slideshow