KSI-101 is novel, potent and high strength (100 mg/mL) antibody-based investigational therapy with a bispecific mechanism of action targeting both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF). Week 20 Data Highlights from Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation – Baseline to Week 20 (Patients dosed at Weeks 0, 4, 8 and 12) Dose Level Accessibility StatementSkip Navigation PALO ALTO, Calif., Nov. 5, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: ...

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]

Core Insights - Kodiak Sciences Inc. is presenting KSI-101, a bispecific investigational biologic targeting macular edema secondary to inflammation, at the 2025 Congress of the International Ocular Inflammation Society in Rio de Janeiro [1][6] - The company aims to address the significant unmet need in treating macular edema caused by inflammation, which can lead to vision loss [3][4] Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on developing therapeutics for retinal diseases, utilizing its ABC Platform for innovative drug design [8][9] - The company is advancing its pipeline, which includes three late-phase clinical assets expected to deliver Phase 3 topline data in 2026 [9] Product Details - KSI-101 is a high-strength (100 mg/mL) bispecific protein designed to target both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), addressing the dual mechanisms of macular edema [6][5] - The ongoing Phase 1b study, APEX, is evaluating the safety and tolerability of KSI-101, with plans to progress into dual Phase 2b/3 studies [7]