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
OpenTimestamps: KOD-KSI101-2026.txt.ots, submitted 2026-10-06 21:17 ET. A proof that this hash existed by then, anchored in Bitcoin and checkable with the standard ots verify client beside the hashed text, without relying on us or on X.
Wayback Machine: snapshot of this page, 2026-10-05 22:24 ET

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.