Kodiak Sciences Completes Enrollment in GLEAM and GLIMMER Phase 3 Clinical Trials of KSI-301 in Patients with Diabetic Macular Edema

– Over 900 patients with diabetic macular edema enrolled worldwide

Excerpt from the Press Release:

PALO ALTO, Calif., Feb. 3, 2022 /PRNewswire/ — Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today announced that it has completed enrollment in its GLEAM and GLIMMER Phase 3 clinical trials of KSI-301, Kodiak’s anti-VEGF antibody biopolymer conjugate, in patients with diabetic macular edema (“DME”).

“Diabetic macular edema is a leading cause of vision loss in working-age people, and the treatment burden imposed by current FDA approved anti-VEGF therapies is challenging for many DME patients,” said Jason Ehrlich, MD, PhD, Kodiak’s Chief Medical and Development Officer. “We are very pleased to have completed enrollment in our GLEAM and GLIMMER pivotal trials, where we are studying KSI-301’s potential to be a longer-lasting DME treatment – as infrequent as once every six months. Enrollment is also proceeding well in our GLOW Phase 3 clinical trial, where we are studying every six-month dosing of KSI-301 in non-proliferative diabetic retinopathy patients who have not yet developed DME.”

“With DAZZLE, BEACON, GLEAM and GLIMMER fully enrolled and with DAYLIGHT recruiting quickly,” said Victor Perlroth, MD, Kodiak’s Chief Executive Officer, “we have line of sight to topline results across the full portfolio of studies to support our single BLA submission for the three major anti-VEGF requiring diseases of wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. We remain on track to announce topline results this quarter for DAZZLE and mid-year for BEACON.”

About KSI-301

KSI-301 is an investigational anti-VEGF therapy built on Kodiak’s Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Kodiak’s objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The KSI-301 clinical program is designed to assess KSI-301’s durability, efficacy and safety in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel.

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