Kodiak Sciences (KOD) has upcoming FDA regulatory milestones for KSI-101. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kodiak Sciences (KOD).
Over the past two years, Kodiak Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KSI-501, KSI-101, and tarcocimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
KSI-501 FDA Regulatory Events
KSI-501 is a drug developed by Kodiak Sciences for the following indication: In Patients With Diabetic Macular Edema.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KSI-501
- Announced Date:
- August 10, 2026
- Indication:
- In Patients With Diabetic Macular Edema
Announcement
Kodiak Sciences Inc. announced that the first patients have been enrolled in the global Phase 3 ALTO trial evaluating KSI-501 in patients with diabetic macular edema (DME).
Read Announcement
KSI-101 FDA Regulatory Timeline and Events
KSI-101 is a drug developed by Kodiak Sciences for the following indication: in patients with MESI.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KSI-101
- Announced Date:
- August 6, 2026
- Target Action Date:
- Q2 2027
- Estimated Target Date Range:
- April 1, 2027 - June 30, 2027
- Indication:
- in patients with MESI
Announcement
Kodiak Sciences Inc. announced that the topline clinical data release anticipated in 2Q 2027
AI Summary
Kodiak Sciences Inc. announced that topline clinical data for KSI-101 in macular edema secondary to inflammation (MESI) are anticipated in the second quarter of 2027. The update is expected to provide important information about the drug’s potential in treating inflammation-related swelling in the macula, a condition that can impair vision.
MESI includes a range of diseases for which no intravitreal biologic therapies are currently available. Existing treatment options can be limited by side effects and tolerability concerns, creating a need for safer and more effective therapies. Kodiak views MESI as a potential market segment distinct from the established anti-VEGF market. The company is evaluating KSI-101 through its PEAK and PINNACLE clinical programs. The expected data release remains subject to clinical development and other risks, so timing and results may change. Kodiak’s statements about the program are forward-looking and should not be viewed as guarantees of future performance.
Read Announcement- Drug:
- KSI-101
- Announced Date:
- August 6, 2026
- Indication:
- in patients with MESI
Announcement
Kodiak Sciences Inc. announced that it has 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").
AI Summary
Kodiak Sciences Inc. announced that it has completed enrollment of the first 300-patient cohort in its PEAK trial. This milestone supports Pivotal Analysis 1 of the company’s KSI-101 Phase 3 program for macular edema secondary to inflammation (MESI).
MESI includes several inflammatory eye diseases that can cause swelling in the macula and threaten vision. Currently, no intravitreal biologic therapies are available to address the full range of MESI conditions. Existing treatments can be limited by side effects and tolerability concerns, creating a need for safer and more effective options.
Kodiak is developing KSI-101 to address this unmet need and potentially establish a treatment option in MESI, a market segment separate from the established anti-VEGF market. Completion of the initial PEAK enrollment represents progress in evaluating the therapy’s safety and effectiveness in patients with inflammation-related macular edema.
Read Announcement- Drug:
- KSI-101
- Announced Date:
- August 6, 2026
- Indication:
- in patients with MESI
Announcement
Kodiak also reaffirmed its plan to release the topline data from Pivotal Analysis 1 in December 2026.
AI Summary
Kodiak Sciences reaffirmed its plan to release topline results from Pivotal Analysis 1 in December 2026. The analysis is part of the company’s clinical development program for KSI-101, an investigational intravitreal biologic being studied in the PEAK and PINNACLE trials. The upcoming data are expected to provide an important update on the therapy’s potential effectiveness and safety in patients with macular edema secondary to inflammation (MESI).
MESI includes a range of inflammatory eye diseases that can cause swelling in the macula and threaten vision. The company notes that no intravitreal biologic therapies are currently available specifically for this disease spectrum. Existing treatments can be limited by side effects and tolerability concerns, creating a need for safer, more effective options. Kodiak also views MESI as a distinct potential market separate from the established anti-VEGF market. The December 2026 data release is therefore a key milestone for KSI-101 and its broader development strategy.
Read Announcement- Drug:
- KSI-101
- Announced Date:
- May 1, 2026
- Indication:
- in patients with MESI
Announcement
Kodiak Sciences announced it will present pipeline advances and clinical results of KSI-101 in a cohort of tertiary care MESI patients at the 2026 American Uveitis Society (AUS) Meeting and the 2026 Association for Research in Vision and Ophthalmology (ARVO) Meeting.
AI Summary
Kodiak Sciences said it will present pipeline advances and clinical results for KSI-101 in a cohort of tertiary care patients with macular edema secondary to inflammation (MESI) at the American Uveitis Society meeting on May 2, 2026 in Aurora, Colorado, and at the Association for Research in Vision and Ophthalmology meeting, May 3–7, 2026 in Denver, Colorado.
Highlights include Phase 1b APEX data on KSI-101, with new results from a tertiary care Asian cohort that were consistent with U.S. findings. Those consistent outcomes support Kodiak’s plan to expand global development, including Phase 3 MESI programs PEAK and PINNACLE. At ARVO, Kodiak will, for the first time, present results from both the U.S. study and the Asian cohort.
Kodiak will have six poster presentations at ARVO; the posters and supporting materials will be posted on Kodiak’s “Scientific Presentations” page on kodiak.com.Read Announcement
- Drug:
- KSI-101
- Announced Date:
- February 4, 2026
- Target Action Date:
- February 7, 2026
- Indication:
- in patients with MESI
Announcement
Kodiak Sciences announced participation at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting on February 7, 2026.
AI Summary
Kodiak Sciences announced it will take part in the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting on February 7, 2026. At the meeting, Dr. Sumit Sharma, a retina and uveitis specialist at the Cole Eye Institute, will present first-time end‑of‑study clinical results from the Phase 1b APEX study, including Week 24 data in patients with macular edema secondary to inflammation (MESI).
The presentation will focus on KSI-101, Kodiak’s intravitreal biologic candidate. Kodiak says there are currently no approved intravitreal biologic therapies that address the full MESI spectrum, and it views MESI as a distinct market separate from anti‑VEGF treatments. Based on APEX results, the two highest dose levels moved forward into Phase 3. The PEAK and PINNACLE Phase 3 studies are actively enrolling MESI subjects at 5 mg and 10 mg doses versus sham.
Read Announcement- Drug:
- KSI-101
- Announced Date:
- November 5, 2025
- Indication:
- in patients with MESI
Announcement
Kodiak Sciences Inc. announced today follow-up data from the APEX study of KSI-101 in patients with MESI.
AI Summary
Kodiak Sciences Inc. announced follow-up data from its Phase 1b APEX study of KSI-101 in patients with macular edema secondary to inflammation (MESI). KSI-101 is a high-strength, bispecific antibody that targets both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF).
Meaningful vision improvements appeared as early as week 4 and continued through week 20. More than half of patients gained at least three lines on the eye chart (≥15 letters). At the highest two dose levels (5 mg and 10 mg), over 90% of patients achieved “real dryness” of the retina, with no intraretinal or subretinal fluid—key signs of disease activity.
The top two doses from APEX have advanced into Phase 3 PEAK and PINNACLE studies, which are enrolling faster than expected. KSI-101 was well tolerated, and Kodiak’s leadership believes these results support its potential as a safe, first-line therapy for a broad MESI population.
Read Announcement- Drug:
- KSI-101
- Announced Date:
- September 15, 2025
- Indication:
- in patients with MESI
Announcement
Kodiak Sciences Inc. announced today new data from the APEX study of KSI-101 presented at the Retina Society 58th Annual Scientific Meeting in Chicago, Illinois.
AI Summary
Kodiak Sciences Inc. announced new data from its Phase 1b APEX study of KSI-101, presented at the Retina Society 58th Annual Scientific Meeting in Chicago. The study, led by Dr. Charles Wykoff, tested KSI-101 in patients with macular edema secondary to inflammation (MESI). Researchers saw rapid vision improvements and retinal drying over 12 weeks.
Patients showed meaningful vision gains as early as week 4, and more than half of those receiving the two highest doses (5 mg and 10 mg) improved by 15 letters or more on the eye chart. A single dose cleared intra- and sub-retinal fluid for most patients, and over 90% achieved retinal dryness by week 8. KSI-101 was well tolerated, with a favorable safety profile. Kodiak is now enrolling patients in its Phase 3 PEAK and PINNACLE studies, testing the 5 mg and 10 mg doses in MESI.
Read Announcement
Tarcocimab tedromer FDA Regulatory Events
Tarcocimab tedromer is a drug developed by Kodiak Sciences for the following indication: In patients with diabetic retinopathy ("DR").
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tarcocimab tedromer
- Announced Date:
- March 26, 2026
- Indication:
- In patients with diabetic retinopathy ("DR").
Announcement
Kodiak Sciences Inc announced positive topline results in the GLOW2 Phase 3 superiority study of Zenkuda™ for the treatment of patients with diabetic retinopathy. Zenkuda (tarcocimab tedromer) is an anti-vascular endothelial growth factor (VEGF) intravitreal biologic built on Kodiak's proprietary antibody biopolymer conjugate (ABC®) platform.
AI Summary
Kodiak Sciences Inc. reported positive topline results from the GLOW2 Phase 3 superiority study of Zenkuda™ for patients with diabetic retinopathy. Zenkuda (tarcocimab tedromer) is an anti-vascular endothelial growth factor (VEGF) intravitreal biologic built on Kodiak’s proprietary antibody biopolymer conjugate (ABC®) platform. The company said the trial met its main goals, suggesting Zenkuda could provide meaningful benefit for people with this eye disease.
Zenkuda also demonstrated superiority in the two alpha-controlled secondary endpoints with high statistical significance. Dr. Victor Perlroth, Kodiak’s CEO, said the data give Zenkuda a multi-indication, BLA-ready profile and that the company intends to accelerate its BLA submission plans. Full end-of-study results will be presented at an upcoming congress by Dr. Charles Wykoff.
Read Announcement- Drug:
- tarcocimab tedromer
- Announced Date:
- March 10, 2025
- Indication:
- In patients with diabetic retinopathy ("DR").
Announcement
Kodiak Sciences Inc. announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ("DR").
AI Summary
Kodiak Sciences Inc. announced that it has successfully completed enrollment for its GLOW2 Phase 3 clinical trial, which is evaluating tarcocimab tedromer in patients with diabetic retinopathy. The trial enrolled over 250 patients, surpassing its initial target. The GLOW2 study closely mirrors the design of the successful GLOW1 trial, with the added benefit of an extra loading dose, providing more dosing flexibility for healthcare providers. With a 48‐week treatment period, all patients are expected to complete their primary endpoint visits by the end of January 2026. Kodiak plans to announce the topline clinical data from GLOW2 in the first quarter of 2026, a step that could support the regulatory filing of tarcocimab if the outcomes continue to show promise in treating diabetic retinopathy.
Read Announcement
