Kodiak Sciences Inc. has completed enrollment in its phase 3 clinical trial evaluating tarcocimab tedromer among patients diagnosed with diabetic retinopathy (DR).
This announcement comes over 2 years after the California-headquartered biopharmaceutical company restarted the candidate’s retinal disease-based clinical program.
Let’s start with a refresh on tarcocimab.
Originally dubbed KSI-301, tarcocimab is an intravitreally (IVT)-administered investigational anti-vascular endothelial growth factor (VEGF) under clinical development as a “mainstay” intravitreal biologic monotherapy providing the following:
- High efficacy and durability
- Flexible 1-month-through-6-month label
Its foundation: Kodiak’s antibody biopolymer conjugate (ABC) platform.
Tell me about this platform.
Positioned at the core of Kodiak’s portfolio, the ABC platform utilizes molecular engineering to merge protein-based and chemistry-based therapies.
Its purpose: Extends to equipping multi-mechanism therapies (such as tarcocimab) with durability and enabling them to block all VEGF-A isoforms.
Specifically: The platform’s conjugate design “leverages a proprietary, phosphorylcholine-based polymer to increase molecular size and extend (the) ocular half-life” of an intravitreal biologic.
- See here to learn more about the four key elements included in its “science of durability.”
Back to tarcocimab; what is it under clinical investigation for?
Besides DR, the candidate is geared toward two other retinal vascular diseases:
- Wet age-related macular degeneration (AMD)
- Retinal vein occlusion (RVO)
Some background on this:
- Kodiak previously halted the tarcocimab program in August 2023 after two phase 3 studies evaluating it for a diabetic macular edema (DME) indication failed to meet their primary efficacy endpoints.
- In November 2023, the company announced plans to reboot the tarcocimab clinical program following positive data from a phase 3 study evaluating it for a potential DR indication.
- Notably: This reboot also included potential indications for two other retinal diseases (wet AMD and RVO) following promising phase 3 data for those diseases.
Talk about this promising data. What did tarcocimab demonstrate?
Looking at its DR indication—specifically: nonproliferative DR (NPDR)—the phase 3 GLOW study (NCT05066230) met its 1-year primary endpoint.
The primary endpoint: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) (Day 1 to Week 48).
The findings:
- Tarcocimab significantly improved diabetic eye disease status and prevented sight-threatening complications.
- Notably, it was also the first time a 6-month dosing schedule in all patients was successful in treating DR—indicating a meaningful and clinically relevant achievement as well as the ABC platform’s durability potential for retinal vascular diseases.
How about for RVO and wet AMD?
Those studies:
- RVO: BEACON pivotal study (NCT04592419)
- See here for the positive data
- Wet AMD: DAYLIGHT pivotal study (NCT04964088)
- See here for the positive data
So how does this new phase 3 trial come into play?
When sharing its plans for a restart of the tarcocimab program, Kodiak’s CEO emphasized:
- “In recent discussions with the FDA … we believe we have a clear regulatory pathway requiring one additional positive study,” stated Kodiak CEO Victor Perlroth, MD, in the company’s announcement.
In other words: The company only needs one more set of positive clinical data in order to submit a single Biologics License Application (BLA) for all three retinal indications.
Ah, gotcha. And this phase 3 study is it?
Indeed it is. Here’s a rundown on the registrational GLOW2 trial (NCT06270836), designed to mirror the original GLOW study—save for an additional loading dose to “provide dosing flexibility for providers,” according to Kodiak CEO Victor Perlroth, MD.
Give me the details.
The study is set up as follows:
- Design: Prospective, randomized, double-masked, multicenter pivotal superiority study
- Participants: +250 DR patients
- Purpose: To evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve DR patients
- Setup: Patients randomized 1:1 to receive either sham or tarcocimab IVT injections at:
- Baseline (Day 1)
- Weeks 4, 8, 20, and 44
- The primary endpoint: Same as the GLOW trial (see above for those details)
- Secondary outcome measures:
- Eyes developing a sight-threatening complication of DR
- Eye improving ≥3 steps on DRSS from baseline at Week 48.
- Secondary outcome measures:
So when can we expect a data readout?
Per Dr. Perlroth, patients are expected to complete their primary endpoint visits by the end of January 2026—with topline clinical data expected in Q1 2026.
Also, keep in mind: The company is close to completing enrollment in the phase 3 wet AMD-focused DAYBREAK study (also evaluating tarcocimab), with topline data expected in Q1 2026.