Kodiak ended the second quarter of 2023 with $378.7M of cash and cash equivalents. “We experienced a significant setback with the recently announced topline data for our Phase 3 GLEAM and GLIMMER studies in diabetic macular edema patients,” said Victor Perlroth, MD, CEO of Kodiak Sciences. “Tarcocimab demonstrated what we see as industry-leading durability together with solid potency, but an unexpected increased rate of cataracts appears to have been the main driver to missing the primary efficacy endpoint in both studies. In our concurrent DAYLIGHT study in age-related macular degeneration where we dosed patients on a high-exposure regimen of 12 monthly doses of tarcocimab, fewer tarcocimab treated patients had a finding of cataract than did aflibercept treated patients. Notwithstanding the negative primary results in GLEAM and GLIMMER, we have two positive Phase 3 studies with tarcocimab: the BEACON study in patients with retinal vein occlusion and the DAYLIGHT study in patients with wet AMD. Following the recent presentation of the GLEAM and GLIMMER data at the American Society of Retina Specialists annual meeting, we have heard encouraging feedback from the retina community that tarcocimab’s 6-month durability profile might be compelling and important for many patients, especially in pseudophakic patients who have already had cataract surgery and make up as many as 40% of anti-VEGF treated patients. While Kodiak has made the business decision to wind down ongoing studies of tarcocimab as previously communicated, we are still evaluating a variety of future options for the tarcocimab program.”
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