Kodiak Sciences Reports Positive Vision Gains from Macular Edema Drug.
ByAinvest
Monday, Sep 15, 2025 8:11 am ET1min read
KOD--
The APEX study, which included patients with macular edema secondary to inflammation, demonstrated that KSI-101 resulted in a significant improvement in best-corrected visual acuity (BCVA) and retinal thickness. Specifically, over 60% of patients in the top two dose levels (5 mg and 10 mg) achieved a 3-line or more gain on the eye chart, equivalent to a 15-letter gain. Additionally, a majority of patients achieved resolution of intra-retinal and sub-retinal fluid, with over 90% showing retinal dryness by week 8.
The Phase 3 PEAK and PINNACLE studies, which are currently enrolling patients, will further evaluate KSI-101's efficacy and safety. These studies will test the top two dose levels of KSI-101 in patients with MESI, comparing it to sham treatment. The primary and key secondary endpoints will be evaluated at week 24.
KSI-101 is a bispecific protein targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), making it a potent and high-strength therapy. The company's focus is on continuing the enrollment of patients into the PEAK and PINNACLE studies.
Kodiak Sciences, a precommercial retina-focused biotechnology company, is committed to researching, developing, and commercializing transformative therapeutics. The company's ABC Platform uses molecular engineering to merge protein-based and chemistry-based therapies, and it is developing a portfolio of three late-stage clinical programs, including KSI-101.
Kodiak Sciences reported new data showing "meaningful" vision gains from its macular edema drug, tarcocimab. The company's Antibody Biopolymer Conjugate (ABC) Platform is a technology platform for retinal medicines. Tarcocimab is an anti-VEGF antibody biopolymer conjugate under development for diabetic retinopathy and wet age-related macular degeneration. Kodiak is also developing KSI-501, a bispecific antibody biopolymer conjugate targeting IL-6 and VEGF, and KSI-101, an unconjugated bispecific protein targeting IL-6 and VEGF.
Kodiak Sciences Inc. (Nasdaq: KOD) has reported promising new data from its Phase 1b APEX study on KSI-101, a novel investigational therapy for macular edema secondary to inflammation (MESI). The study, presented at the Retina Society's 58th Annual Scientific Meeting in Chicago, showed that KSI-101 achieved clinically meaningful vision gains and rapid retinal drying in patients with MESI.The APEX study, which included patients with macular edema secondary to inflammation, demonstrated that KSI-101 resulted in a significant improvement in best-corrected visual acuity (BCVA) and retinal thickness. Specifically, over 60% of patients in the top two dose levels (5 mg and 10 mg) achieved a 3-line or more gain on the eye chart, equivalent to a 15-letter gain. Additionally, a majority of patients achieved resolution of intra-retinal and sub-retinal fluid, with over 90% showing retinal dryness by week 8.
The Phase 3 PEAK and PINNACLE studies, which are currently enrolling patients, will further evaluate KSI-101's efficacy and safety. These studies will test the top two dose levels of KSI-101 in patients with MESI, comparing it to sham treatment. The primary and key secondary endpoints will be evaluated at week 24.
KSI-101 is a bispecific protein targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), making it a potent and high-strength therapy. The company's focus is on continuing the enrollment of patients into the PEAK and PINNACLE studies.
Kodiak Sciences, a precommercial retina-focused biotechnology company, is committed to researching, developing, and commercializing transformative therapeutics. The company's ABC Platform uses molecular engineering to merge protein-based and chemistry-based therapies, and it is developing a portfolio of three late-stage clinical programs, including KSI-101.

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