Kodiak Sciences Inc. (Nasdaq: KOD), a US-based biopharmaceutical company, announced on Friday that it has completed enrolment in its GLOW Phase three clinical trial of tarcocimab tedromer (KSI-301), the company's anti-VEGF antibody biopolymer conjugate, in patients with Non-Proliferative Diabetic Retinopathy (NPDR) without diabetic macular edema (DME).
The product is an investigational anti-VEGF therapy based on the company's Antibody Biopolymer Conjugate (ABC) Platform and is aimed at maintaining potent and effective drug levels in ocular tissues for longer than present available agents.
The Phase 3 GLOW study is a global, multi-centre, randomised pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in approximately 240 patients with treatment-naïve, moderately severe to severe NPDR. Patients are randomised to receive either tarcocimab tedromer every six months after initiating doses given at baseline, 8 weeks and 20 weeks into the study, or to receive placebo injections. The primary endpoint is at one year and patients will be treated and followed for two years.
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