Daniil Gataulin

Michael DiFiore

- Kodiak Sciences announced new data from its Phase 1b APEX study for **KSI-101**, an investigational therapy for Macular Edema Secondary to Inflammation (MESI).  **[1468748_20250915SF73116:0]** 
- The study demonstrated **clinically meaningful vision gains**, with more than half of patients in the top two dose levels improving **3-lines or more** on the eye chart, and **rapid retinal drying**, with over **90%** of patients achieving retinal dryness by Week 8.  **[1468748_20250915SF73116:0]** 
- **KSI-101** continued to show a favorable safety profile, and the Phase 3 PEAK and PINNACLE studies are actively enrolling patients, with topline data expected in **4Q 2026 or 1Q 2027**.  **[1468748_20250915SF73116:0]** **[1468748_20250915SF73116:3]**

Kodiak Sciences announces positive Phase 1b APEX study data for KSI-101 in MESI

- Kodiak Sciences Inc. (Nasdaq: KOD) announced it will present Phase 1b APEX data for **KSI-101** in macular edema secondary to inflammation (MESI) at The 25th EURetina Congress on **September 5, 2025**, and The Retina Society 58th Annual Scientific Meeting on **September 13, 2025**.  **[1468748_20250902SF63061:0]** 
- KSI-101 is a novel bispecific protein targeting IL-6 and VEGF, developed for MESI, which Kodiak believes represents a **new market segment** with no current intravitreal biologic therapies.  **[1468748_20250902SF63061:0]** 
- The Phase 1b APEX study for KSI-101 demonstrated **meaningful visual and anatomical gains** and good tolerability, leading to the advancement of two dose levels into the Phase 3 program (PEAK and PINNACLE studies) for MESI.  **[1468748_20250902SF63061:0]** 
- Topline data readouts for the KSI-101 Phase 3 studies are expected in **4Q 2026 or 1Q 2027**.  **[1468748_20250902SF63061:1]**  Kodiak also anticipates topline data for its other late-stage programs, Tarcocimab and KSI-501, in **1Q 2026 and 3Q 2026**, respectively.  **[1468748_20250902SF63061:1]**

Kodiak Sciences (KOD)