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-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-101 FDA Regulatory 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:
- 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.
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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 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.
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