Core Insights - Kodiak Sciences Inc. announced new data from the APEX study of KSI-101, a novel therapy for macular edema secondary to inflammation (MESI), presented at the Retina Society Annual Scientific Meeting [1][2] Group 1: Study Findings - The APEX Phase 1b study showed that patients with MESI experienced clinically meaningful gains in best-corrected visual acuity (BCVA) and rapid retinal drying by Week 12 [2][5] - In the study, the proportion of patients achieving a 15-letter gain in BCVA was 31% at the 2.5 mg dose, 62% at the 5 mg dose, and 54% at the 10 mg dose [5] - The mean change in BCVA from baseline to Week 12 was +8.8 letters for 2.5 mg, +10.7 letters for 5 mg, and +12.1 letters for 10 mg [5] - Patients with diabetic macular edema (DME) also showed significant visual and anatomical improvements, gaining an average of 12.0 letters and reducing retinal thickness by 157 microns by Week 24 [5] Group 2: Mechanism and Safety - KSI-101 is a bispecific antibody targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), designed to treat MESI [4][10] - The therapy demonstrated a favorable safety profile, being well tolerated in both MESI and DME patients [6][12] - The drying effect of KSI-101 was reported to be comparable or superior to existing treatments like Ozurdex, without associated side effects [7] Group 3: Future Developments - Ongoing Phase 3 studies, PEAK and PINNACLE, are actively enrolling patients to further evaluate KSI-101 at the 5 mg and 10 mg dose levels [8][14] - The studies aim to cover a wide spectrum of MESI patients, with PEAK focusing on more severe cases and PINNACLE on milder cases [14] - Topline data readouts for KSI-101 are expected in late 2026 or early 2027, indicating a significant market opportunity for the treatment of MESI [17]