Kodiak Sciences Reports Positive Phase 1b APEX Study Results for KSI-101 in MESI

Chicago, IL — Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial biotechnology company focused on retinal diseases, announced new data from its Phase 1b APEX study of KSI-101 in patients with macular edema secondary to inflammation (MESI). Results were presented at the Retina Society 58th Annual Scientific Meeting by Dr. Charles Wykoff, MD, PhD.

Key Clinical Outcomes

• Rapid vision gains: Meaningful improvement achieved as early as Week 4.
• ≥15-letter gain (3 lines on eye chart):
  - 2.5 mg: 31% of patients
  - 5 mg: 62% of patients
  - 10 mg: 54% of patients
• Mean BCVA improvement at Week 12:
  - +8.8 letters (2.5 mg)
  - +10.7 letters (5 mg)
  - +12.1 letters (10 mg)
• Anatomical response:
  - Reduction in retinal thickness: -165 μm (2.5 mg), -216 μm (5 mg), -240 μm (10 mg).
  - Over 90% of patients achieved retinal dryness by Week 8.
• Hospitalization of retinal fluid: Single dose of KSI-101 resolved intra- and sub-retinal fluid in most patients.
• Diabetic macular edema (DME) cohort: Patients (n=12) gained +12 letters and saw a 157 μm reduction in thickness at Week 24.

Safety Profile

• KSI-101 was well tolerated in both MESI and DME patients.
• No major safety concerns reported.
• Safety allowed advancement of 5 mg and 10 mg dose levels into Phase 3 studies.

Expert Commentary

Dr. Sumit Sharma (Cleveland Clinic, Cole Eye Institute):

“KSI-101 produced a drying effect on par with or better than steroid implants like Ozurdex—but without side effects. If replicated in Phase 3, KSI-101 could transform MESI treatment.”

Dr. Charles Wykoff (Blanton Eye Institute):

“Although still early, KSI-101 shows dual-action efficacy and safety across a range of inflammatory retinal diseases where no approved treatments exist. The retina community looks forward to Kodiak’s Phase 3 programs.”

Dr. Victor Perlroth, CEO of Kodiak Sciences:

“KSI-101 combines IL-6 inhibition and VEGF trapping in a potent bispecific design. Its rapid action, broad activity, and favorable safety distinguish it as a potential unifying treatment for MESI.”

Ongoing Phase 3 Studies

• PEAK (NCT06990399): Evaluating moderate to severe MESI patients.
• PINNACLE (NCT06996080): Enrolling milder MESI patients, as well as those with good vision but moderate-to-severe edema.
• Design:
  - Doses: 5 mg and 10 mg vs. sham.
  - Monthly dosing for 6 months, then individualized through Week 44.
  - Primary and key secondary endpoints assessed at Week 24.
• Timelines: Topline results expected late 2026 to early 2027.

About KSI-101

• High-concentration (100 mg/mL) bispecific protein.
• Dual mechanism: IL-6 antibody inhibition + VEGF trap.
• Designed to address MESI, a heterogeneous group of vision-threatening conditions caused by inflammation and blood-retinal barrier disruption.
• Represents a new treatment category, distinct from established anti-VEGF therapies.

About Kodiak Sciences

Kodiak Sciences (Nasdaq: KOD) is a retina-focused biotechnology company developing next-generation medicines to address leading causes of blindness. Its ABC Platform merges protein and chemistry-based design to engineer durable biologics.

• Late-stage pipeline includes:
  - Tarcocimab and KSI-501 (Phase 3, anti-VEGF space, topline readouts in 2026).
  - KSI-101 (Phase 3 in MESI, topline readout expected late 2026/early 2027).

Kodiak aims to bring transformative retinal therapies to patients globally.

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