Kodiak Sciences completes enrollment in phase 3 GLOW2 trial of tarcocimab tedromer in patients with diabetic retinopathy

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Kodiak Sciences has completed enrollment in its GLOW2 phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy (DR).

GLOW2 (NCT06270836) is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in over 250 treatment-naïve patients with DR. Patients in the study are randomized 1:1 to receive either sham injections or tarcocimab 5mg via intravitreal injection at baseline, week 4, 8, 20, and 44.^1,2

The primary endpoint is the proportion of eyes improving greater than or equal to 2 steps on Diabetic Retinopathy Severity Scale (DRSS) from baseline at week 48. Additional outcome measures include the proportion of eyes developing a sight-threatening complication of diabetic retinopathy and the proportion of eyes improving greater than or equal to 3 steps on DRSS from baseline at week 48. Sight-threatening complications include diabetic macular edema, new or worsening proliferative diabetic retinopathy, and anterior segment neovascularization.^1,2

According to the company, tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary antibody biopolymer conjugate (ABC) platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents.

To date, tarcocimab has been evaluated successfully in 3 phase 3 pivotal clinical studies: the phase 3 GLOW1 study in DR, the phase 3 BEACON study in retinal vein occlusion, and the phase 3 DAYLIGHT study in wet age-related macular degeneration (AMD). In addition to the GLOW2 study, tarcocimab is also being evaluated in the DAYBREAK study for the treatment of wet AMD.

Victor Perlroth, MD, CEO of Kodiak, commented on the trial in a press release from the company.¹

"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,” said Perlroth.

Allen Hu, MD, top enroller in the GLOW2 study and principal investigator at Cumberland Valley Retina Consultants commented on tarcocimab in the press release, saying, “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."

Topline clinical data from the GLOW2 trial is expected in Q1 2026.¹

Reference:

1. Kodiak Sciences completes enrollment in second registrational trial of tarcocimab in patients with diabetic retinopathy. Published March 11, 2025. Accessed March 11, 2025.https://ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-completes-enrollment-second-registrational-trial

2. A study to evaluate the efficacy and safety of tarcocimab tedromer compared with sham treatment in participants with diabetic retinopathy (DR) (GLOW2). Kodiak Sciences. NCT06270836. Https://clinicaltrials.gov/study/NCT06270836?Tab=table