Trial results

$KOD — KSI-101

Kodiak Sciences Inc. (KOD) KSI-101: trial results in Macular edema secondary to inflammation (MESI), 2026.

Research by Catalyst Intel · Published 2026-09-29 22:49 ET

The catalyst

"We also remain on track to announce topline data in December 2026 for KSI-101 in the Phase 3 PEAK study in patients with macular edema secondary to inflammation (MESI), in which KSI-101 is being evaluated for superiority against sham-treated patients."

— Kodiak Sciences Inc., 8-K filed 2026-09-28 · the filing. Checked word for word against the stored document when this page was built; a sentence that did not check out would not be here.

Event id: KOD-KSI101-2026
Company: Kodiak Sciences Inc.
Kind: Trial results
Indication: Macular edema secondary to inflammation (MESI)
Window: 2026-12-01 – 2026-12-31
Status: bar_published

The bar

Published 2026-09-29 22:49 ET, before the event. The text below is the hashed text: paste it into the verify page and your browser will recompute the same digest.

At a glance

Pass if: Floor: disclose a BCVA gain of at least 10 letters, using the prior APEX early-response magnitu… · Bar: disclose at least 15 letters of BCVA gain, matching the prior APEX visual-response magnitu…

Great if (any one): Differentiator: at least 90% complete absence of IRF and SRF, indicating retinal dryness. [“In… · Differentiator: OCT CST below 325 microns as an anatomical response signal. [“Rapid vision impr…

9 items we could not source — full detail below

EVENT KOD-KSI101-2026
SCORED SET ITT
FLOOR floor_bcva_signal Floor: disclose a BCVA gain of at least 10 letters, using the prior APEX early-response magnitude. ["Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups." - ## prior_topline_pr_8]
BAR bar_bcva_gain Bar: disclose at least 15 letters of BCVA gain, matching the prior APEX visual-response magnitude. ["More than half of patients achieved ≥15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels." - ## prior_topline_pr_8]
DIFF diff_retinal_dryness Differentiator: at least 90% complete absence of IRF and SRF, indicating retinal dryness. ["In top dose groups, ≥90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture." - ## prior_topline_pr_8]
DIFF diff_oct_cst Differentiator: OCT CST below 325 microns as an anatomical response signal. ["Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups." - ## prior_topline_pr_8]

SHA-256: 11987fd3719caf576d6019b042d6758a5e06c84ad1ae7db01084c5391f36220b
Frozen: yes
Public post: https://x.com/i/web/status/2105127830623326547

Criteria as committed

Floor — all must pass

Id	Field	Test	As written
`floor_bcva_signal`	`BCVA letter gain`	`>= 10`	Floor: disclose a BCVA gain of at least 10 letters, using the prior APEX early-response magnitude. [“Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups.” — ## prior_topline_pr_8]

Bar — all must pass

Id	Field	Test	As written
`bar_bcva_gain`	`BCVA letter gain`	`>= 15`	Bar: disclose at least 15 letters of BCVA gain, matching the prior APEX visual-response magnitude. [“More than half of patients achieved ≥15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels.” — ## prior_topline_pr_8]

Differentiators — one upgrades IN_LINE to BEAT

Id	Field	Test	As written
`diff_retinal_dryness`	`Complete absence of IRF and SRF`	`>= 90`	Differentiator: at least 90% complete absence of IRF and SRF, indicating retinal dryness. [“In top dose groups, ≥90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture.” — ## prior_topline_pr_8]
`diff_oct_cst`	`OCT CST`	`< 325`	Differentiator: OCT CST below 325 microns as an anatomical response signal. [“Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups.” — ## prior_topline_pr_8]

What we could not source before the event

No ClinicalTrials.gov record or NCT identifier for a single KSI-101 PEAK event; primary_outcome cannot be populated.
No document states the primary-result analysis population; scored_set is null.
No explicit numerical PEAK success criterion, responder-rate target, superiority margin, alpha, confidence-interval requirement, or statistical decision rule.
No arm-level sample size, treatment-versus-sham event rates, p-value, confidence interval, or safety event rates for Pivotal Analysis 1.
No exact APEX responder-rate target; the source says “more than half,” not a percentage.
No numeric KSI-101 safety-rate threshold suitable for a veto.
No manual comparator data or external historical comparator links; the comparator file is a placeholder.
analysis population: ITT — ESTIMATED — no document states the primary result's population; the documents describe a randomized comparison, analysed on every randomized patient unless the protocol says otherwise; change it in the editor if the protocol says otherwise

Verdicts

No verdict has been published for this event yet.