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Kodiak Sciences Treats First Patients in Three Phase 3 Studies of KSI-301 - Two Studies in Diabetic Macular Edema and One Study in Macular Edema Due to Retinal Vein Occlusion
- Concurrent development program compares Kodiak's long-acting anti-VEGF antibody biopolymer conjugate KSI-301 to standard of care in all major retinal
About this update from Kodiak Sciences Inc
[{"type":"text","content":"- Concurrent development program compares Kodiak's long-acting anti-VEGF antibody biopolymer conjugate KSI-301 to standard of care in all major retinal disease indications: wet AMD, DME, and RVO.\n - Kodiak also announces completion of U.S. patient enrollment in DAZZLE, its ongoing Phase 2b/3 study of KSI-301 in wet AMD.\n - Phase 1b durability data continue to improve as they mature further: 72% of wet AMD patients and 79% of DME patients have now achieved a 6-month or longer treatment free interval at least once during follow-up; 81% of RVO patients have achieved a 4-month or longer interval.\n\n\nPALO ALTO, Calif., Oct. 5, 2020 /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 the first patients have been treated in the randomized, double-masked GLEAM, GLIMMER and BEACON studies, three pivotal Phase 3 studies of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER) and macular edema due to retinal vein occlusion (BEACON). \nRecruitment of patients from the United States in Kodiak's ongoing global DAZZLE Phase 2b/3 study of KSI-301 in treatment-naïve wet (neovascular) age-related macular degeneration is now complete. Recruitment in Europe is ongoing, and Kodiak expects to complete DAZZLE enrollment this year.\nAdditional Phase 1b study data continue to show strong durability of KSI-301 compared to the current standard of care. In treatment-naïve patients, after only three loading doses, 72% of wAMD and 79% of DME patients have now achieved a six-month or longer treatment free interval at least once during follow-up. In RVO, 81% of patients have achieved a four-month or longer treatment free interval at least once during follow-up.\n\"Kodiak continues to make strong operational progress toward our 2022 Vision of submitting a single BLA for KSI-301 in wet AMD, DME and RVO, the main diseases treated today using intravitreal anti-VEGF therapy,\" said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. \"The randomization of treatment-naïve patients into these three pivotal studies in the third quarter is a critical step to build the clinical evidence for KSI-30...