Kodiak's Phase 3 GLOW Study In Diabetic Retinopathy Meets Primary Goal

(RTTNews) - Kodiak Sciences Inc. (NASDAQ: KOD) Monday said Phase 3 GLOW study of tarcocimab tedromer in patients with diabetic eye disease met its primary goal.

The study evaluated the company's proprietary ABC (antibody biopolymer conjugate) Platform based investigational therapy tarcocimab tedromer in patients with non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Diabetic macular edema (DME) is a swelling of the macula, the part of the retina responsible for central fine vision.

In the pivotal GLOW study, NPDR patients were randomized to receive either tarcocimab every six months after initiating doses given at baseline, 8 weeks and 20 weeks into the study, or to receive sham injections.

The study met its primary endpoint with 41.1% of patients showing at least 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) score, a grading system measuring the degree of retinopathy, compared to 1.4% of patients in the sham group.

"We now have three successful phase 3 pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases: wet AMD, RVO and NPDR. In recent discussions with the FDA, which included the GLOW data, we believe we have a clear regulatory pathway requiring one additional positive study to support a single BLA submission for all three indications," said Victor Perlroth, CEO of Kodiak.