Kodiak Sciences Inc. Completes Enrollment in GLOW2 Phase 3 Clinical Trial
PALO ALTO, Calif., March 10, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today 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," concluded Dr. Hu.
About the Phase 3 GLOW2 Study
The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with diabetic retinopathy ("DR"). Patients are randomized 1:1 and receive either sham injections or tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥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 ≥3 steps on DRSS from baseline at Week 48. Additional information about GLOW2 (also called Study KS301P108) can be found on www.clinicaltrials.gov under Trial Identifier NCT06270836 (https://clinicaltrials.gov/show/NCT06270836).
About tarcocimab tedromer (tarcocimab, KSI-301)
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.
About diabetic retinopathy and tarcocimab
Diabetic retinopathy is a common complication of diabetes that affects the eye. If left untreated, diabetic retinopathy progresses and eventually can lead to serious vision-threatening complications, such as diabetic macular edema and proliferative diabetic retinopathy. It is estimated that of the 36 million American adults living with diabetes, approximately 10 million have diabetic retinopathy and fewer than 1% will choose to be treated with today's available medicines due to the high treatment burden associated with frequent injections. Long interval dosing is particularly important in the diabetic retinopathy population, and our GLOW1 and GLOW2 studies are designed to explore the ability of tarcocimab, with all patients on an every 6-month dosing interval, to directly improve the disease (the primary endpoint) and to prevent vision threatening complications from the worsening of the disease (key secondary endpoint).
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the expected timing of patients in the GLOW2 Phase 3 study completing their primary endpoint visits and announcement of topline clinical data; the anticipation of having a regulatory package for tarcocimab that is ready to file; the ability of DAYBREAK to broaden the potential efficacy profile for tarcocimab in wet AMD and complete the BLA package; the ability to complete enrollment in DAYBREAK to enable topline clinical data announcement in 2Q 2026; the plan to file a single BLA for tarcocimab in wet AMD, DR and RVO; the potential for tarcocimab to change the treatment landscape in diabetic retinopathy and help millions of patients; the probability of the DAYBREAK study meeting the primary endpoint of non-inferiority in visual acuity gains; the potential of KSI-501 to be a first-in-class bispecific ABC inhibiting VEGF and IL-6 and its potential to provide extended durability; and the potential activation of Phase 2b/3 PEAK and PINNACLE studies in patients with macular edema secondary to inflammation ("MESI"). Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "anticipate," "pursue," and other similar expressions among others.
About Kodiak Sciences Inc.
Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally.
