#United States #Palo Alto #Kodiak Sciences #Tarcocimab #GLOW2 Trial

Kodiak Sciences Completes Enrollment in GLOW2 Phase 3 Trial

On March 10, 2025, Kodiak Sciences Inc. (Nasdaq: KOD) revealed that it has successfully completed the patient enrollment phase in its GLOW2 Phase 3 clinical trial. This pivotal study focuses on tarcocimab tedromer, an investigational treatment aimed at individuals suffering from diabetic retinopathy (DR). This announcement marks a significant step in the company’s ongoing commitment to addressing retinal diseases, which pose considerable risks of vision loss for millions worldwide.

The GLOW2 trial is designed as a prospective, randomized, double-masked, multi-center study intended to evaluate the safety and efficacy of tarcocimab in treatment-naïve DR patients. With more than 250 patients enrolled, Kodiak exceeded its initial enrollment target, creating hope for a future where DR management could see important advancements. The study will focus on the primary endpoint of whether patients improve by at least two steps on the Diabetic Retinopathy Severity Scale (DRSS) by week 48, which will occur by January 2026.

Victor Perlroth, M.D., the CEO of Kodiak, expressed enthusiasm about the successful enrollment, stating, "With its 48-week treatment duration, we expect to unveil our topline clinical data in the first quarter of 2026." He highlighted that the GLOW2 study design closely resembles that of the GLOW1 study, which successfully achieved its main endpoint alongside key secondary outcomes with strong statistical significance.

A notable aspect of the GLOW2 trial is the inclusion of an initial loading dose, which provides more flexibility in dosing options for healthcare providers. This could greatly benefit patients who are often required to undergo frequent injections under current treatment protocols. Dr. Allen Hu, principal investigator at Cumberland Valley Retina Consultants, emphasized the potential of tarcocimab to drastically alter the landscape of DR treatment. He noted that fewer than 1% of diabetic retinopathy patients currently receive treatment due to the burdens of frequent injections.

If the outcomes from the GLOW2 trial are similar to those from the GLOW1 study, which indicated positive results and showed a promising therapeutic profile, tarcocimab may become a pivotal new treatment option. Dr. Hu stated, "With only four doses in the first year and subsequent doses every six months, tarcocimab can potentially transform the way we treat diabetic retinopathy, helping millions avoid the serious complications linked with untreated DR."

The urgency surrounding DR remains high, given its status as a prevalent complication of diabetes, affecting an estimated 10 million adults in the United States. Left untreated, DR can progress to severe vision-threatening conditions, making innovative treatments like tarcocimab essential in addressing this pressing health concern.

The GLOW2 and DAYBREAK Phase 3 studies are both crucial for Kodiak Sciences' development of tarcocimab across DR and wet age-related macular degeneration (wet AMD). The goal is to file a single Biologics License Application (BLA) for tarcocimab spanning multiple related conditions, which underscores the company's strategy to create a robust therapeutic profile for the drug in various retinal diseases.

In the context of the current healthcare system, where many patients with diabetic retinopathy are left untreated, the results from these studies could lead to breakthroughs that not only improve clinical outcomes but also enhance the quality of life for countless individuals affected by retinal diseases.

Kodiak Sciences remains dedicated to advancing the science behind retinal health, harnessing innovative biopharmaceutical technologies to combat leading causes of blindness globally. As the trial progresses, the medical community, patients, and caregivers alike are eager to see if tarcocimab meets its anticipated endpoints and ultimately transforms diabetic retinopathy management.