Palo Alto, California, August 6, 2026
Kodiak Sciences Inc. has completed enrollment of the first pivotal 300-patient cohort in its Phase 3 PEAK trial evaluating KSI-101 for macular edema secondary to inflammation (MESI) and reaffirmed that topline clinical data from the cohort remain on track for release in December 2026. The enrollment milestone supports Pivotal Analysis 1 of Kodiak’s global Phase 3 KSI-101 development program and represents an important step toward evaluating the investigational therapy across patients with significant inflammatory retinal disease. The company also expects enrollment of a second pivotal cohort involving 600 patients across the PEAK and PINNACLE studies to be completed in the fourth quarter of 2026, with topline results from that analysis anticipated in the second quarter of 2027. Kodiak said the Phase 3 program builds on findings from its earlier Phase 1b APEX study and is designed to determine whether KSI-101 can provide a new intravitreal biologic treatment option for MESI.
KSI-101 Targets IL-6 and VEGF in Inflammatory Eye Disease
KSI-101 is a novel, high-strength bispecific protein designed to simultaneously target interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), two pathways relevant to inflammation and vascular permeability in retinal disease. The investigational therapy is being developed specifically for MESI, a heterogeneous group of conditions characterized by macular edema, visual impairment, inflammation and disruption of the blood-retinal barrier. Kodiak reported that its Phase 1b APEX dose-finding study produced encouraging anatomical and visual responses, with more than half of treated patients achieving gains of at least 15 letters in best-corrected visual acuity. The company also reported substantial resolution of intraretinal and subretinal fluid at higher dose levels, while KSI-101 was generally well tolerated in the study. These early findings supported advancement of the 5 mg and 10 mg dose levels into the pivotal Phase 3 PEAK and PINNACLE trials. However, the Phase 1b findings remain preliminary and the ongoing pivotal studies are intended to establish the therapy’s efficacy and safety in larger patient populations.
PEAK and PINNACLE Cover Broad Spectrum of MESI Patients
The PEAK and PINNACLE Phase 3 trials are superiority studies comparing KSI-101 with sham treatment and share similar study designs while enrolling complementary patient populations. PEAK focuses on patients with moderate-to-severe macular edema and vision impairment, whereas PINNACLE includes patients with milder macular edema and any degree of vision impairment, as well as patients with more substantial edema but relatively preserved vision. Together, the studies are intended to evaluate KSI-101 across a broad spectrum of MESI. Participants assigned to KSI-101 receive six fixed monthly doses through Week 20, followed by individualized dosing through Week 44. Primary and key secondary endpoints are evaluated at Week 24. Pivotal Analysis 1 covers the first 300 PEAK patients, while Pivotal Analysis 2 includes another 300 PEAK patients and 300 PINNACLE participants.
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December 2026 Readout Marks Key Clinical Milestone
Kodiak’s upcoming December 2026 topline readout will provide the first pivotal assessment of whether KSI-101’s earlier clinical activity translates into a larger Phase 3 population. The company notes that there are currently no available intravitreal biologic therapies addressing the broad spectrum of MESI diseases, while existing treatments can face tolerability and safety limitations. The program therefore represents an effort to establish a distinct treatment approach outside the established anti-VEGF retinal vascular disease market. Kodiak is a pre-commercial biotechnology company focused on retinal medicines and currently has three late-stage clinical programs. Alongside KSI-101, its pipeline includes Zenkuda™ and KSI-501 for retinal vascular diseases. Completion of the first PEAK pivotal cohort places KSI-101 closer to a potentially important Phase 3 efficacy and safety inflection point, with December’s results expected to help determine the future regulatory and clinical development trajectory of the program.
Source: Kodiak Sciences press release
