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.
