Follow-up data for Kodiak's KSI-101 from the APEX study showed continued strengthening of clinical effect (≥90% of patients achieving absence of intraretinal and subretinal fluid) through week 20 in macular edema secondary to inflammation (MESI)

Core Insights - Kodiak Sciences Inc. announced follow-up data from the APEX study of KSI-101, a novel therapy for macular edema secondary to inflammation (MESI), indicating significant potential for this treatment in improving visual acuity and retinal health [1][4][18] Group 1: KSI-101 Overview - KSI-101 is a bispecific antibody targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), designed to treat MESI, a group of serious retinal diseases characterized by macular edema and visual impairment [3][7] - The therapy has shown a favorable safety profile and is well tolerated among patients [3][5] Group 2: APEX Study Results - In the APEX study, patients receiving KSI-101 demonstrated meaningful visual acuity gains, with 38% to 62% of patients achieving a 15-letter gain on the eye chart across different dose levels [3][5] - The mean change in best corrected visual acuity (BCVA) from baseline to week 20 was +11.8 to +15.4 ETDRS letters, with corresponding BCVA scores reaching approximately 20/32 to 20/25 [3][5] - 90% of patients in the top two dose levels achieved sustained retinal dryness, indicating a significant reduction in disease activity [5][6] Group 3: Future Studies and Market Potential - The Phase 3 studies, PEAK and PINNACLE, are actively enrolling patients and are designed to evaluate the efficacy of KSI-101 at the 5 mg and 10 mg dose levels [10][11] - These studies aim to cover a wide spectrum of MESI patients, with PEAK focusing on more severe cases and PINNACLE on milder cases [11][12] - Kodiak believes that KSI-101 has the potential to become a cornerstone therapy for MESI, addressing a significant unmet need in the market [4][6][8]