Kodiak Sciences Announces Topline Results from its Phase 3 Studies of Tarcocimab Tedromer in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema and Provides Update on Tarcocimab Development Program

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[{"type":"text","content":"PALO ALTO, Calif., July 24, 2023 /PRNewswire/ -- Kodiak Sciences Inc. (NASDAQ: KOD) announced today topline results from three Phase 3 studies of tarcocimab tedromer, a novel antibody biopolymer conjugate.\nThe DAYLIGHT study was a randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of a high intensity dosing regimen of tarcocimab tedromer in 557 treatment-naïve subjects with wet AMD. The DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every 8 weeks following 3 monthly loading doses. Tarcocimab was safe and well tolerated in the study and with a low rate of intraocular inflammation.\nThe GLEAM and GLIMMER studies are identically designed, randomized, double-masked, active comparator-controlled studies evaluating the efficacy, durability and safety of tarcocimab tedromer in 460 and 457 treatment-naïve subjects with DME, respectively. Although high proportions of patients on meaningfully longer treatment intervals were observed with tarcocimab, with half of patients on every 24-week dosing at the primary endpoint, the GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept given every 8 weeks after 5 monthly loading doses. An unexpected increase in cataracts was observed over time in the tarcocimab arms of both GLEAM and GLIMMER, and Kodiak's initial evaluation suggests that this contributed meaningfully to the failure of each study. In the DAYLIGHT study, no imbalance in cataracts was observed between wet AMD patients receiving tarcocimab or aflibercept throughout the one-year study period despite the intensive monthly tarcocimab dosing regimen.\nBased on these data, and despite demonstrating great potential, Kodiak has made a business decision to discontinue further development of tarcocimab.\n\"A successful efficacy, durability and safety outcome in both GLEAM and GLIMMER was the basis of our regulatory and clinical development strategy for tarcocimab,\" said Victor Perlroth, MD, Kodiak's Chief Executive Officer, in explaining the decision. \"After our unsuccessful Phase 2b study in wet AMD last year, we made a number of changes to the GLEAM and ...

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