US biopharmaceutical company Kodiak Sciences Inc (Nasdaq:KOD) announced on Monday that it has completed enrolment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy (DR).

The prospective, randomised, double-masked, multi-centre pivotal superiority study is designed to assess the efficacy and safety of tarcocimab tedromer in treatment-naive patients with DR. Patients enrolled in the study are randomised 1:1 and receive either sham injections or tarcocimab through intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The study's primary endpoint is the proportion of eyes improving greater than or equal to two 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 at least three steps on DRSS from baseline at Week 48.

Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (ABC) Platform and is being developed as a 'mainstay' intravitreal biologic monotherapy intended to provide high efficacy and high durability and a flexible 1-month through 6-month label.

Victor Perlroth, MD, Kodiak chief executive officer, said: "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 enrolment 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)."