Kodiak Completes Phase 3 GLOW2 Trial Enrollment for DR

Kodiak Sciences has successfully completed patient enrollment for its Phase 3 GLOW2 trial, evaluating the efficacy and safety of tarcocimab tedromer in individuals with diabetic retinopathy (DR).

About the GLOW2 Phase 3 Clinical Trial

GLOW2 (NCT06270836) is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to assess tarcocimab tedromer’s efficacy and safety in over 250 treatment-naïve diabetic retinopathy patients. Key details of the study include:

• Study Design: Patients were randomized 1:1 to receive either sham injections or tarcocimab 5mg via intravitreal injection at baseline, week 4, 8, 20, and 44.

• Primary Endpoint: The proportion of eyes improving by ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at week 48.

• Secondary Endpoints:

• Proportion of eyes improving by ≥3 steps on the DRSS from baseline at week 48.

• Proportion of eyes developing sight-threatening complications, including diabetic macular edema (DME), new or worsening proliferative diabetic retinopathy (PDR), and anterior segment neovascularization.

Tarcocimab Tedromer: A Next-Generation Anti-VEGF Therapy

Tarcocimab tedromer is an investigational anti-VEGF therapy developed using Kodiak's proprietary antibody biopolymer conjugate (ABC) platform. This innovative design allows the drug to maintain effective therapeutic levels in ocular tissues longer than currently available agents, potentially offering extended treatment intervals and improved patient adherence.

To date, tarcocimab has been evaluated in three Phase 3 pivotal clinical trials, including:

• GLOW1 – Evaluating diabetic retinopathy (DR)

• BEACON – Investigating retinal vein occlusion (RVO)

• DAYLIGHT – Assessing wet age-related macular degeneration (AMD)

In addition to GLOW2, tarcocimab is also being evaluated in the DAYBREAK study for wet AMD.

Expert Insights on GLOW2 and Tarcocimab’s Potential

Kodiak’s CEO, Victor Perlroth, MD, highlighted the significance of the GLOW2 trial in the company’s press release:

“The GLOW2 design mirrors that of our successful GLOW1 study, with the advantage of an additional loading dose to provide dosing flexibility for providers. GLOW2 is our second registrational study in diabetic retinopathy, and if there is a successful outcome, we anticipate having a regulatory package for tarcocimab that is ready to file.”

Dr. Allen Hu, MD, top enroller in GLOW2 and principal investigator at Cumberland Valley Retina Consultants, also expressed optimism about tarcocimab’s potential impact:

“With only 4 doses in year 1 and every 6-month dosing in every patient, the GLOW1 data showed us as a community that tarcocimab can potentially achieve strong efficacy both in treating existing disease and preventing disease progression in diabetic retinopathy. If GLOW2 mirrors these results, I believe tarcocimab as a biologic with twice-yearly dosing in all patients can change the treatment landscape in diabetic retinopathy and help millions of patients.”

What’s Next?

Topline data from the GLOW2 trial is expected in Q1 2026. If successful, these findings could position tarcocimab as a breakthrough therapy for diabetic retinopathy, offering extended dosing intervals and durable disease control—a significant advancement for both patients and clinicians.