Live News • 10h
Kodiak Sciences Begins Phase 3 ALTO Trial for KSI-501 in Diabetic Macular Edema Kodiak Sciences has enrolled the first patients in its global Phase 3 ALTO trial of KSI-501 for diabetic macular edema. The study aims to show superiority versus aflibercept by targeting both IL-6-mediated inflammation and VEGF-mediated vascular permeability, and by testing two extended-interval dosing regimens.
The trial assesses whether KSI-501’s dual mechanism can provide deeper and more sustained disease control in diabetic macular edema, which is currently treated with single-pathway agents such as aflibercept.
Kodiak Sciences shares trade at US$42.11, with the stock up 61.8% year to date. Expectations around the KSI-501 program and its Phase 3 path are likely an important sentiment driver.
The key takeaway is that KSI-501 has moved into a pivotal testing phase, where trial design, execution, and comparative data versus aflibercept will be central considerations for Kodiak Sciences. Live News • Aug 08
Kodiak Sciences Hits Key Enrollment Milestone in KSI-101 Phase 3 PEAK Trial Kodiak Sciences has finished enrolling the first 300-patient pivotal cohort in its Phase 3 PEAK trial of KSI-101 for macular edema secondary to inflammation and kept guidance for topline data from this Pivotal Analysis 1 in December 2026.
The company expects enrollment of a second pivotal cohort of 600 subjects across the PEAK and PINNACLE studies to complete in Q4 2026, with topline data for that cohort planned for Q2 2027, outlining a clear near-term and medium-term clinical news pipeline.
Kodiak Sciences shares trade at about $45.37, with the stock up roughly 74.4% year to date, indicating that recent trading has already been sensitive to progress in the KSI-101 program.
The main takeaway is that Kodiak Sciences now has firmer timelines around two major KSI-101 data events, which concentrates both opportunity and clinical trial risk into late 2026 and the first half of 2027. Announcement • Aug 06
Kodiak Sciences Inc. Completes Enrollment In First Pivotal Cohort In The Phase 3 PEAK Trial Of KSI-101 For Macular Edema Secondary To Inflammation And Reaffirms Topline Clinical Data Release Remains On Track For December 2026 Kodiak Sciences Inc. completed enrollment of the first 300-patient cohort in its PEAK trial, supporting Pivotal Analysis 1 of the KSI-101 Phase 3 program in macular edema secondary to inflammation ("MESI"). Completion of enrollment in the second pivotal cohort evaluating 600 subjects across the PEAK and PINNACLE studies is expected in Fourth Quarter 2026, with topline clinical data release anticipated in Second Quarter 2027. KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF for the treatment of MESI. Data from our dose-finding Phase 1b APEX study demonstrated robust anatomical and visual responses across MESI patients. More than half of patients achieved =15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels. Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST 90% resolution of intraretinal ("IRF") and subretinal fluid ("SRF") by Week 8 and 20/25 Snellen visual acuity by Week 20. In top dose groups, =90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture. KSI-101 also continued to be well tolerated with a favorable safety profile. The top two dose levels in APEX have been advanced into the Phase 3 pivotal studies, PEAK and PINNACLE. The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients. Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN. The primary and key secondary endpoints will be evaluated at Week 24. Topline data readouts for Pivotal Analysis 1 (PEAK patients 1 – 300) and Pivotal Analysis 2 (PEAK patients 301 – 600 and PINNACLE patients 1 – 300) are expected in December 2026 and Second Quarter 2027, respectively. 
