Kodiak Sciences Inc. announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ("DR").

"We randomized more than 250 patients into our GLOW2 Phase 3 study, exceeding our enrollment target," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak. "With its 48-week duration of treatment, all patients are expected to complete their primary endpoint visits by the end of January 2026, and we expect to announce topline clinical data in 1Q 2026."

"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. We remain focused on completing enrollment in our ongoing DAYBREAK Phase 3 study to broaden the efficacy profile for tarcocimab in wet age-related macular degeneration ("wet AMD"), and it is our plan to wait for DAYBREAK topline data expected in 2Q 2026 in order to file a single BLA for tarcocimab in wet AMD, DR and Retinal Vein Occlusion ("RVO")," concluded Dr. Perlroth.

Dr. Allen Hu, top enroller in the GLOW2 study and principal investigator at Cumberland Valley Retina Consultants commented on tarcocimab's potential in DR. "Fewer than 1% of subjects with diabetic retinopathy are treated today due to high treatment burden associated with frequent injections needed with today's approved therapies. If diabetic retinopathy is left untreated, the majority of patients —and this is millions of patients— will experience disease progression and develop vision-threatening complications. 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.