Kodiak Sciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the research, development, and commercialization of therapeutics for retinal diseases. Its product pipeline includes KSI-301 for wet AMD, KSI-301 for diabetic eye disease, KSI-501 for DME and uveitis, KSI-201 for resistant wet AMD, and KSI-401 for dry AMD. The company was founded by Stephen A. Charles and Victor Perlroth in 2009 and is headquartered in Palo Alto, CA.
Clinical Trials
44
33 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
33
75.0%
Completed
3
6.8%
Recruiting
3
6.8%
Terminated
5
11.4%
No approval data available
- Zenkuda (tarcocimab tedromer) met the DAYBREAK primary endpoint with a p-value of 0.0007, showing vision gains and retinal drying in wet AMD. - Tabirafusp-ted (KSI-501) met its vision primary endpoint at p=0.0036 and the anatomical key secondary endpoint at p<0.0001. - Both agents achieved non-inferiority in vision gains versus aflibercept at year one, with 54% of Zenkuda patients on 6-month dosing. - Kodiak plans a multi-indication Zenkuda BLA in the fourth quarter of 2026 covering five positive Phase 3 studies in wAMD, DR and RVO.
- Kodiak Sciences will report topline results from the DAYBREAK Phase 3 study on September 28, 2026, evaluating Zenkuda and KSI-501 in wet age-related macular degeneration. - DAYBREAK runs two investigational arms in parallel within a single registrational trial, testing non-inferiority against aflibercept on visual acuity change from baseline. - Zenkuda already has a BLA-ready profile in diabetic retinopathy and retinal vein occlusion, while KSI-501, a bispecific targeting VEGF and IL-6, has no approved indication. - Kodiak's third program, KSI-101 in macular edema secondary to inflammation, has two BLA-facing Phase 3 studies with analyses expected in December 2026 and the second quarter of 2027.
- Kodiak Sciences has completed enrollment of the first 300-patient cohort in the Phase 3 PEAK trial of KSI-101 for macular edema secondary to inflammation (MESI), with topline data expected in December 2026. - KSI-101 is a novel bispecific protein targeting both IL-6 and VEGF, and there are currently no approved intravitreal biologic therapies for the spectrum of MESI diseases. - Phase 1b APEX data showed robust efficacy, with more than half of patients achieving ≥15-letter gains in best corrected visual acuity and over 90% resolution of intraretinal and subretinal fluid by Week 8. - The second pivotal cohort, encompassing 600 subjects across the PEAK and PINNACLE studies, is expected to complete enrollment in Q4 2026 with topline data anticipated in Q2 2027.
- The FDA approved Roche's Susvimo (ranibizumab injection) 100 mg/mL in May 2025 as the first continuous-delivery therapy for diabetic retinopathy, requiring only one refill every nine months. - The approval was supported by positive data from the Phase III Pavilion trial and applies to patients who have previously responded to at least two anti-VEGF injections. - Diabetic retinopathy affects nearly 10 million people in the US and over 100 million worldwide, with prevalence rising with age and affecting 15–30% of the diabetic population. - The diabetic retinopathy market is projected to grow significantly through 2036, driven by rising diabetes prevalence, novel pipeline candidates, and sustained-release treatment innovations.
- Kodiak Sciences' experimental drug Zenkuda met its primary endpoint in a late-stage trial for diabetic retinopathy, with 62.5% of patients achieving at least a two-step improvement on a standard retinopathy severity scale at 48 weeks compared to 3.3% on sham treatment. - Patients treated with Zenkuda demonstrated an 85% reduction in risk of developing sight-threatening complications such as progression to proliferative diabetic retinopathy. - The drug was well-tolerated with no reported cases of vision-threatening conditions, and Kodiak plans to accelerate its FDA submission based on these results. - Kodiak Sciences shares surged 68.6% following the announcement, reaching their highest level in more than four years.
- Kodiak Sciences' Zenkuda demonstrated 62.5% of patients achieved ≥2-step improvement in diabetic retinopathy severity score versus 3.3% with sham control (p<0.0001) in the Phase 3 GLOW2 confirmatory study. - The treatment showed an 85% risk reduction in developing sight-threatening complications such as proliferative diabetic retinopathy or diabetic macular edema compared to sham control. - Zenkuda maintained an exceptional safety profile with zero cases of intraocular inflammation, retinal vasculitis, or occlusive retinal vasculitis reported throughout the study. - The positive results position Kodiak for accelerated BLA submission plans and validate the company's six-month dosing interval approach for diabetic retinopathy treatment.
- Kodiak Sciences will present final Phase 1b APEX study results for KSI-101, a bispecific protein targeting IL-6 and VEGF, at the Angiogenesis 2026 meeting on February 7. - The 24-week data demonstrate robust anatomic and visual improvements in patients with macular edema secondary to inflammation (MESI), regardless of underlying etiology or inflammation location. - KSI-101 represents a potential first-line unifying therapy for MESI, addressing an unmet medical need with no currently available intravitreal biologic therapies for this spectrum of diseases. - Two Phase 3 studies, PEAK and PINNACLE, are actively enrolling patients at 5 mg and 10 mg dose levels, with topline data expected in 4Q 2026 and 2Q 2027 respectively.
- Over 60% of patients receiving KSI-101 at top dose levels achieved 3-line or more vision gains in the Phase 1b APEX study for macular edema secondary to inflammation. - A single dose of KSI-101 resulted in over 90% of patients achieving retinal dryness by week 8, with meaningful vision gains observed as early as week 4. - The bispecific protein targeting IL-6 and VEGF showed broad activity across different types of inflammatory macular edema, potentially offering a unifying treatment approach. - Two Phase 3 studies, PEAK and PINNACLE, are actively enrolling patients to test the top two dose levels (5 mg and 10 mg) versus sham treatment.
- VelaVigo Bio has licensed its first-in-class bispecific antibody VBS-102 to Ollin Biosciences for up to $440 million in upfront fees and milestone payments. - The deal grants Ollin exclusive global rights excluding Greater China, marking VelaVigo's second major licensing agreement within six months. - VelaVigo will receive tiered royalties on sales and maintain development rights for the Greater China market. - The transaction validates VelaVigo's BD+VC business model following a successful $50 million Pre-A funding round in February 2025.
• Kodiak Sciences has successfully enrolled over 250 patients in its GLOW2 Phase 3 trial of tarcocimab tedromer for diabetic retinopathy, with topline data expected in Q1 2026. • The GLOW2 study mirrors the successful GLOW1 trial design with an additional loading dose, potentially offering a twice-yearly dosing regimen that could transform treatment for millions of diabetic retinopathy patients. • If successful, Kodiak plans to file a single Biologics License Application for tarcocimab covering wet AMD, diabetic retinopathy, and retinal vein occlusion following completion of the DAYBREAK study in Q2 2026.
