Charles C. Wykoff, MD, PhD, FASRS
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Dr. Wykoff presents results from the phase 3 GLOW2 trial of tarcocimab tedromer (Zenkuda, Kodiak) for the treatment of diabetic retinopathy. The positive findings support an upcoming biologics license application submission, he notes.
Posted: 7/28/2026
Charles C. Wykoff, MD, PhD, FASRS
Dr. Wykoff presents results from the phase 3 GLOW2 trial of tarcocimab tedromer (Zenkuda, Kodiak) for the treatment of diabetic retinopathy. The positive findings support an upcoming biologics license application submission, he notes.
Posted: 7/28/2026
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Hi, I'm Charles Wykoff from Houston, Texas, retina specialist here at the American Society of Retina Specialists 2026 in Montreal, Canada. Privileged to be able to share data today from a phase 3 clinical trial on behalf of my co-investigators. This was the GLOW2 clinical trial, first time clinical trial data presentation. So GLOW2 is the second phase 3 diabetic retinopathy trial with an anti-VEGF called tarcocimab. Tarcocimab has been studied for a while, multiple previous trials. We understand this molecule quite well. This is an anti-VEGF biologic, and in this trial, the formulation was 20% free antibody and then 80% biopolymer conjugated for durability. This was a superiority trial, a double-masked randomized global clinical trial comparing tarcocimab five milligrams to sham injections in 255 patients with NPDR or PDR. The trial design was five injections of tarcocimab through one year, three initial monthly doses, a three-month interval, and then a six-month interval for, again, five doses over one year.
Primary endpoint was at one year DRSS step change compared to baseline. So at baseline, about half of patients were on GLP-1 agonists. Almost a fifth had PDR. The majority had DRSS level 47, some had 53, and four patients had DRSS level of 43 ultimately. So from a primary endpoint perspective, the primary endpoint was met with 63% of tarcocimab patients achieving a two or more step DRSS improvement compared to about 3% with the sham arm. And we saw that these DRSS improvements with tarcocimab were consistent at the six-month interval since the last injection, which was week 44, or at a one-month interval after the last injection, which was at week 48, showing good durability with six months dosing. And then probably more clinically relevant was the key secondary endpoint of development of vision threatening complications. So the development of PDR was reduced with tarcocimab by 85%.
So from about 16% with sham to about 2.5% with tarcocimab. And in this analysis, PDR and DME with the vision threatening complications with DME being defined as a CST of 375 microns or 350 microns with a five letter loss. All the other secondary analyses were as expected, probably most interestingly from the field. The use or not use of GLP-1 agonists did not appear to have any impact on the tarcocimab benefit for patients. So looking forward, the summary from GLO-1 and LO2, because again, GLO2 was the second diabetic retinopathy trial with tarcocimab, is that now we've seen good efficacy across a broad spectrum of patients with diabetic retinopathy and also good safety. And a multi-indication BLA for tarcocimab targeting the FDA is in preparation. Thank you.
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